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Zero-P VA. Variable angle zero-profile anterior cervical interbody fusion (ACIF) device. Technique Guide

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Page 1: Zero-P VA. Variable angle zero-profile anterior cervical ...synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · Variable angle zero-profile anterior cervical interbody

Zero-P VA. Variable angle zero-profileanterior cervical interbody fusion (ACIF)device.

Technique Guide

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Table of Contents

Zero-P VA Instruments and Implants Technique Guide Synthes

Image intensifier control

Introduction

Surgical Technique

Product Information

Bibliography

Zero-P VA Instruments and Implants 2

AO Principles 4

Indications and Contraindications 5

Preoperative Planning 6

Implant Insertion 7

Screw Fixation 13Option A: Awl and Self-Drilling Screws 14Option B: Drill Guide 19Option C: Angled Instruments 24

Implant Removal 29

Implants 32

Instruments 33

Instrument Disassembly 36

Set List(s) 38

Bibliography 42

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Zero-P VA. Variable angle zero-profile anterior cervical interbody fusion (ACIF) device.

The Zero-P VA implant is a stand-alone implant for use in cervical interbody fusion,1–4 which combines the functionalityof a cervical interbody spacer and the benefits of an anteriorcervical plate.

Zero-profile midline– Designed to reduce the risk of contacting local

anatomical structuresThe Zero-P VA implant does not extend beyond the confinesof the intervertebral space midline, limiting risk of contactwith vessels and adjacent soft tissues

– Designed to prevent contact with adjacent levels Cervical plates placed near the adjacent level discs maycontribute to bone formation near or around the adjacentlevel, which may lead to future complications5

Ease of use– Variable angle screws, designed with a wide range of

allowable screw trajectories, potentially facilitate screw insertion

– One-step blocking mechanism features audible, tactileand visual cues to confirm screw is blocked upon insertion

– Because the interbody plate and stops assembly is pre-attached to the spacer, the interbody plate and stops assembly is automatically aligned upon implant insertion.This avoids the process of aligning and realigning an anterior cervical plate

2 Synthes Zero-P VA Instruments and Implants Technique Guide

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PEEK interbody spacer– Includes a radiopaque marker for posterior visualization

during imaging– Spacer component is made of pure medical grade PEEK

Optima (polyetheretherketone)– Teeth on the superior and inferior implant surfaces provide

initial stability

Titanium alloy interbody plate and stops assembly– Stresses in the interbody plate and stops assembly are

decoupled from the spacer through an innovative interface– Contralateral safety stops designed to reduce the risk of

over-insertion and align with the anterior surface of thevertebral bodies

Variable angle screws– Can be inserted 27°–44° (17° range) in cranial-caudal

direction and 15°–29° (14° range) in medial-lateral direction

– Variable angle and nominal angle insertion technique options

– Designed to resist graft expulsion– Self-drilling and self-tapping options– Screws are allowed to toggle post-operatively within

vertebral bodies, which may potentially reduce or limitload shielding of the graft in the event of graft subsidence

Zero-P VA Instruments and Implants Technique Guide Synthes 3

17.5 mm

15 mm

0.9 mm

40° (nominal)

13.6 mm

23° (nominal)

14°range

17°range

29°15°

44°

27°

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AO Principles

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation.6 They are:– Anatomic reduction– Stable fixation– Preservation of blood supply– Early, active mobilization

The fundamental aims of fracture treatment in the limbs and the fusion of the spine are the same. A specific goal inthe spine is returning as much function as possible to theneural elements.7

4 Synthes Zero-P VA Instruments and Implants Technique Guide

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Indications and Contraindications

IndicationsThe Synthes Zero-P VA implant is a stand-alone anterior cervical interbody fusion device indicated for use in skeletallymature patients with degenerative disc disease (DDD) withaccompanying radicular symptoms at one level from C2–T1.DDD is defined as discogenic pain with degeneration of thedisc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment.The interior of the spacer component of the Zero-P VA implantshould be packed with autogenous bone graft and implantedvia an anterior approach.

Contraindications1. Use of the Synthes Zero-P is contraindicated when there

is active systemic infection, infection localized to the siteof the proposed implantation, or when the patient hasdemonstrated allergy or foreign body sensitivity to any of the implant materials.

2. Severe osteoporosis may prevent adequate fixation andthus preclude the use of this or any other orthopaedic implant.

3. Severe obesity or degenerative diseases, are relative con-traindications. The decision whether to use these devicesin such conditions must be made by the physician takinginto account the risks versus the benefits to the patient.

4. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may inter-fere with their ability to follow postoperative restrictions.These patients may place undue stresses on the implantduring bony healing and may be at a higher risk of implant failure.

5. Prior fusion at the level to be treated.6. Any condition not described in the Indications for Use.

Zero-P VA Instruments and Implants Technique Guide Synthes 5

Please refer to product insert for complete system description, indications and warnings.

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Preoperative Planning

Determine the surgical approach, and estimate the appropriateZero-P VA implant size.

Notes – With the segment fully distracted, the Zero-P VA implant must fit firmly between the end plates before screws are inserted. When rocking the insertion device backward and forward in a cranial to caudal direction, no toggling of the implant should be evident.– It is recommended to select the maximum implant size in order to optimize the stability of the segment through tension in the annulus fibrosis and longitudinal ligaments.

6 Synthes Zero-P VA Instruments and Implants Technique Guide

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Zero-P VA Instruments and Implants Technique Guide Synthes 7

Implant Insertion

1ApproachUsing the standard surgical approach, expose the vertebralbodies to be fused. Prepare the fusion site following the appropriate technique for the given indication.

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Implant Insertion

8 Synthes Zero-P VA Instruments and Implants Technique Guide

2Determine appropriate implant

Instruments

03.647.720– Zero-P VA Trial Spacers with stop, parallel, .729 5–12 mm heights, purple

03.647.750– Zero-P VA Trial Spacers with stop, lordotic,.759 5–12 mm heights, blue

03.647.780– Zero-P VA Trial Spacers with stop, convex,.789 5–12 mm heights, gold

Optional instrument

03.820.113 Slotted Mallet

Choose a parallel, lordotic, or convex trial spacer of the appropriate height. Selection of the trial spacer depends onthe height of the intervertebral space, the preparation technique, and patient anatomy.

Position the trial spacer in the correct cranial /caudal alignmentand carefully insert it into the disc space.

The mallet can be used to help insert and/or remove the trial spacer.

Trial spacers have depth stops corresponding to the depthstops of the Zero-P VA implant.

Caution: Anterior osteophytes in the surgical site that preventdesired positioning of a trial spacer will likely prevent desiredpositioning of the Zero-P VA implant. It is recommended toremove interfering anterior osteophytes before implant insertion.

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Zero-P VA Instruments and Implants Technique Guide Synthes 9

Notes – Trial spacers are color-coded by shape. The height of the trial spacer is 0.8 mm less than that of the corresponding implant to account for penetration of the teeth into the vertebral end plate.– Trial spacers are not for implantation and must be removed before insertion of the Zero-P VA implant.– To minimize potential risk of injuring the patient, it is recommended to trial with smaller height trial spacers before trialing with taller height trial spacers.– Although the trial spacers have depth stops, use of an image intensifier is recommended to check the position during insertion. With the segment fully distracted, the trial spacer must fit tightly and accurately between the end plates.

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10 Synthes Zero-P VA Instruments and Implants Technique Guide

Implant Insertion

3Pack implant with autogenous bone graft

Instruments

03.647.970 Cancellous Bone Impactor

03.647.984 Packing Block, for Zero-P VA

Place the Zero-P VA implant into the packing block.

Use the cancellous bone impactor to firmly pack the autoge-nous bone graft into the implant cavities.

Note: To ensure optimal contact with the vertebral endplates,it is important to fill the implant until the autogenous bonegraft protrudes from the perforations in the spacer.

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4Insert implant

Instrument

03.647.963 Insertion Device, for Zero-P VA

Optional instruments

03.617.981 Impactor, flat

03.647.980 Implant Holder for Zero-P VA

03.647.982 Impactor, ball tip

03.826.113 Slotted Mallet

Use the insertion device or implant holder to introduce theimplant into the disc space.

Using the insertion deviceAttach the insertion device to the implant by aligning the recessed grooves located midline on the anterior face of theimplant with the pronged tabs of the device tip. Squeeze theinsertion device handles to secure the implant; the thumbnut on the insertion device may then be advanced clockwiseto lock the implant to the insertion device.

Carefully insert the implant into the distracted segment. Advance the implant until the implant stops rest on the anterior surface of the vertebral body.

If necessary, the top of the insertion device can be tappedwith a mallet to further advance the implant into the discspace. If distraction has been applied, release the distraction,leaving the insertion device attached to the implant.

Zero-P VA Instruments and Implants Technique Guide Synthes 11

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Implant Insertion

Using the implant holderAlternatively, the implant can be carefully inserted into thedisc space with the forceps-style implant holders. Attach theimplant holder to the implant by aligning the recessed grooveslocated midline on the anterior face of the implant with theends of the implant holder. Once the implant is partially introduced into the disc space, the implant can be advancedusing the flat and/or ball tip impactors.

Notes– The Zero-P VA interbody plate is marked with an arrow to indicate implant orientation. When inserting the Zero-P VA implant, the arrow should point to the cranial vertebral body upon insertion.– Verify final implant position relative to the vertebral bodies in the AP and lateral directions with the help of an intraop erative x-ray. A posterior x-ray marker incorporated in the PEEK spacer enables accurate intraoperative radiographic assessment of implant position.

12 Synthes Zero-P VA Instruments and Implants Technique Guide

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Screw Fixation

The Zero-P VA system is only intended to be implanted withtwo Zero-P VA screws, forming a stand-alone interbody fusionconstruct. By design, the Zero-P VA system enables insertionof the screws within a range of acceptable trajectories.

Nominal angle and variable angle instruments are availableto prepare screw holes prior to screw insertion. Using an instrument to prepare screw holes is recommended; these instruments are designed to facilitate subsequent placementof screws at the desired trajectory.– Variable angle instruments are designed for flexibility;

both the variable angle awl and variable angle drill guideenable hole preparation within the full range of acceptablelimits. Variable angle instruments are marked with a doublegreen band at the tip.

– Nominal angle instruments are designed for repeatability;both the nominal angle awl and nominal angle drill guideenable hole preparation at the nominal trajectory. Nominalangle instruments are marked with a single green band atthe tip.

Zero-P VA Instruments and Implants Technique Guide Synthes 13

Variable angle insertion

Nominal angle insertion

Screw Penetration (mm)

Screw AP Cranial /CaudalLength (mm) Min Nominal Max Min Nominal Max

12 9.9 11.4 12.3 2.2 4.7 5.0

14 11.3 12.9 14.0 3.1 5.9 6.3

16 12.7 14.3 15.7 4.0 7.2 7.7

18 14.1 15.3 17.5 4.9 8.0 9.0

Caution: Depending on the selected screw length and instrumentation used, the screws may extend beyond theposterior edge of the implant.

The screw trajectory achieved during screw insertion will result in varied screw penetration into the vertebral bodies.

23° (nominal)40° (nominal)

NominalMax

Min

14°range17°

range

29°15°

44°

27°

Nominal

Max

MinAP

Cranial/Caudal

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A1Create first pilot hole

Instruments

03.647.963 Insertion Device, for Zero-P VA

03.647.994 2.5 mm Awl with sleeve, variable angle

Optional instruments

03.647.980 Implant Holder, for Zero-P VA

03.647.990 2.5 mm Awl with sleeve, nominal angle

Determine the entry point and trajectory for the first screw.The correct angulations for the screws range between27°–44° cranial /caudal and 15°–29° medial / lateral.

Insert the awl into the first screw hole of the interbody plate.To ensure proper angle of pilot hole, fully seat the outer sleevetip of the awl into the interbody plate. Push down on the ballhandle of the awl while simultaneously twisting the handleto advance the awl. Remove the awl while maintaining alignment of the hole and implant.

Screw Fixation

Option A: Awl and Self-drilling Screws

A recommended screw fixation technique is to create pilotholes and then insert self-drilling screws.

14 Synthes Zero-P VA Instruments and Implants Technique Guide

40° (nominal) 23° (nominal)

14°range17°

range

29°15°

44°

27°

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Important: Intraoperative imaging should be used to verifyawl position.

Notes– When using the awl, the insertion device and/or implant holder should be used to minimize implant movement.– The tip of the awl fits into the screw hole of the interbody plate to produce the correct angle.– The upper shaft of the awl, near the awl handle, is marked with two black rings. When advancing the awl, the appropriate depth has been reached when the end of the outer sleeve is flush with the first ring and only the second ring is still visible.

Caution: Do not use the awl without the sleeve; use of theawl without the sleeve may cause injury to the patient.

Zero-P VA Instruments and Implants Technique Guide Synthes 15

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Screw FixationOption A: Awl and Self-drilling Screws

A2Insert first screw

Instruments

03.617.904 Screw Inserter, T8, self-retaining, quickcoupling

03.647.903 Handle with quick coupling, small

03.647.963 Insertion Device, for Zero-P VA

Optional instruments

03.647.901 Holding Sleeve, for StarDrive screwinserter, T8

03.647.980 Implant Holder, for Zero-P VA

Select the appropriate screw length according to the preop-erative plan and intraoperative findings.

Attach the screw inserter to the handle then load the selected3.7 mm self-drilling screw to the assembled driver. The screwwill self-retain on the driver, but the holding sleeve may beused for additional screw retention.

Advance the screw until the screwhead passes beyond theblocking feature of the interbody plate. Visually verify screwis blocked by the blocking feature.

Note: When inserting screws, the insertion device and/orimplant holder should be used to minimize implant movement.

Important: Intraoperative imaging should be used to verifyscrew position and to verify the screw follows the trajectoryof the pilot hole created by the awl.

16 Synthes Zero-P VA Instruments and Implants Technique Guide

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A3Insert second screwRepeat Steps A1 and A2 for the second screw.

Zero-P VA Instruments and Implants Technique Guide Synthes 17

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Screw FixationOption A: Awl and Self-drilling Screws

18 Synthes Zero-P VA Instruments and Implants Technique Guide

A4Final tighten screws

Instruments

03.617.904 Screw Inserter, T8, self-retaining, quickcoupling

03.647.903 Handle with quick coupling, small

03.647.963 Insertion Device, for Zero-P VA

Optional instrument

03.647.980 Implant Holder, for Zero-P VA

To fully secure the implant, use the screw inserter to advanceeach screw another 1/4–1/2 turn. This final tightening step (1)lags the stops of the interbody plate to the anterior surfaceof the vertebral bodies and (2) increases the apposition ofthe implant to the vertebral body endplates.

Note: When tightening screws, the insertion device and/orimplant holder should be used to minimize implant movement.

Caution: Do not continue advancing any screw after the stopsof the interbody plate are lagged to the anterior surface ofthe vertebral bodies and do not advance any screw more than1/2 turn during final tightening. Over-tightening may strip boneand compromise fixation of the implant in vertebral bodies.

1

2

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Zero-P VA Instruments and Implants Technique Guide Synthes 19

B1Drill first pilot hole

Instruments

03.617.912 2.0 mm Drill Bit with 12 mm stop, quickcoupling

03.617.914 2.0 mm Drill Bit with 14 mm stop, quickcoupling

03.617.916 2.0 mm Drill Bit with 16 mm stop, quickcoupling

03.647.903 Handle with quick coupling, small

03.647.964 Drill Guide with handle, variable angle

03.647.963 Insertion Device, for Zero-P VA

Optional instruments

03.647.980 Implant Holder, for Zero-P VA

03.647.962 Drill Guide with handle, Nominal Angle

Determine the entry point and trajectory for the first screw.The correct angulations for the screws range between 27°–44° cranial /caudal and 15°–29° medial/lateral.

Insert the drill guide into the screw hole of the interbody plate.To ensure proper angle of pilot hole, fully seat the tip of thedrill guide into the interbody plate. Insert the drill bit into theguide and drill until the stop of the drill contacts the guide.

Screw Fixation

Option B: Drill Guide

Alternatively, use a drill guide and drill to create a pilot hole.Then insert either self-drilling or self-tapping screws.

40° (nominal) 23° (nominal)

14°range17°

range

29°15°

44°

27°

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Screw FixationOption B: Drill Guide

Select a drill bit of appropriate length and assemble the drillbit to the handle. Insert the drill bit into the drill guide anddrill until the stop on the drill bit contacts the drill guide.

Remove the drill bit and drill guide.

Important: Intraoperative imaging should be used to verifydrill bit position.

Notes– The drill bits are marked with a colored ring corresponding to the color-coded screw lengths. When the ring is flush with the top of the drill guide, the appropriate depth has been reached.– When drilling, the insertion device and/or implant holder should be used to minimize implant movement.

Caution: When drilling, care should be taken to drill on-axis,in the same trajectory as the drill guide. Applying side loadsand/or levering off-axis during drilling may result in brokenor damaged instruments which may potentially cause harmto the patient.

20 Synthes Zero-P VA Instruments and Implants Technique Guide

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Zero-P VA Instruments and Implants Technique Guide Synthes 21

B2Insert first screw

Instruments

03.617.904 Screw Inserter, T8, self-retaining, quickcoupling

03.647.903 Handle with quick coupling, small

03.647.963 Insertion Device, for Zero-P VA

Optional instruments

03.647.901 Holding Sleeve, for StarDrive screwinserter, T8

03.647.980 Implant Holder, for Zero-P VA

Select the appropriate screw length according to the preop-erative plan and intraoperative findings.

Attach the screw inserter to the handle, then load the selected3.7 mm self-tapping screw to the assembled driver. The screwwill self-retain to the driver, but the holding sleeve may beused for additional screw retention.

Advance the screw until the screw head passes beyond theblocking feature of the interbody plate. Visually verify screwis blocked by the blocking feature.

Note: When inserting screws, the insertion device and/or implant holder should be used to minimize implant movement.

Important: Intraoperative imaging should be used to verifyscrew position and to verify the screw follows the trajectoryof the pilot hole created by the drill.

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22 Synthes Zero-P VA Instruments and Implants Technique Guide

Screw FixationOption B: Drill Guide

B3Insert second screwRepeat Steps B1 and B2 for the second screw.

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Zero-P VA Instruments and Implants Technique Guide Synthes 23

B4Final tighten screws

Instruments

03.617.904 Screw Inserter, T8, self-retaining, quickcoupling

03.647.903 Handle with quick coupling, small

03.647.963 Insertion Device, for Zero-P VA

Optional instrument

03.647.980 Implant Holder, for Zero-P VA

To fully secure the implant, use the screw inserter to advanceeach screw another 1/4–1/2 turn. This final tightening step (1)lags the stops of the interbody plate to the anterior surfaceof the vertebral bodies and (2) increases the apposition ofthe implant to the vertebral body endplates.

Note: When tightening screws, the insertion device and/orimplant holder should be used to minimize implant movement.

Caution: Do not continue advancing any screw after the stopsof the interbody plate are lagged to the anterior surface of thevertebral bodies and do not advance any screw more than 1/2turn during final tightening. Over-tightening may strip boneand compromise fixation of the implant in vertebral bodies.

1

2

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24 Synthes Zero-P VA Instruments and Implants Technique Guide

C1Create first pilot hole

Instruments

03.647.963 Insertion Device, for Zero-P VA

03.647.993 2.5 mm Angled Awl

03.820.113 Slotted Mallet

Optional instrument

03.647.980 Implant Holder, for Zero-P VA

Determine the entry point and trajectory for the screw. Thecorrect angulations for the screws range between 27°–44°cranial /caudal and 15°–29° medial / lateral.

Insert the awl at the appropriate angle into the first screwhole of the interbody plate and tap with the slotted malletuntil the awl is seated. Remove the awl while maintainingalignment of the hole and implant.

Screw Fixation

Option C: Angled Instruments

When screws are difficult to drill or insert due to interferinganatomy, the angled awl and angled screwdriver may be used.

40° (nominal) 23° (nominal)

14°range17°

range

29°15°

44°

27°

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Zero-P VA Instruments and Implants Technique Guide Synthes 25

Important: Intraoperative imaging should be used to verifyawl position.

Note: When using the angled awl, the insertion deviceand/or implant holder should be used to minimize implantmovement.

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26 Synthes Zero-P VA Instruments and Implants Technique Guide

Screw FixationOption C: Angled Instruments

C2Insert first screw

Instrument

03.617.900 Angled StarDrive Screwdriver, T8, withsleeve, self-retaining

Select the appropriate screw length according to the preoperative plan and intraoperative findings.

Load the selected 3.7 mm self-drilling screw onto the angledscrewdriver. Advance the screw until the screwhead passesbeyond the blocking feature of the interbody plate. Visuallyverify screw is blocked by the blocking feature.

Note: When inserting screws, the insertion device and/orimplant holder should be used to minimize implant movement.

Important: Intraoperative imaging should be used to verifyscrew position and to verify the screw follows the trajectoryof the pilot hole created by the angled awl.

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Zero-P VA Instruments and Implants Technique Guide Synthes 27

C3Insert second screwRepeat Steps C1 and C2 for the second screw.

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Screw FixationOption C: Angled Instruments

28 Synthes Zero-P VA Instruments and Implants Technique Guide

C4Final tighten screws

Instruments

03.617.900 Angled StarDrive Screwdriver, T8, withsleeve, self-retaining

03.647.963 Insertion Device, for Zero-P VA

Optional instrument

03.647.980 Implant Holder, for Zero-P VA

To fully secure the implant, use the screw inserter to advanceeach screw another 1/4–1/2 turn. This final tightening step (1)lags the stops of the interbody plate to the anterior surfaceof the vertebral bodies and (2) increases the apposition ofthe implant to the vertebral body endplates.

Note: When tightening screws, the insertion device and/orimplant holder should be used to minimize implant movement.

Caution: Do not continue advancing any screw after thestops of the interbody plate are lagged to the anterior surfaceof the vertebral bodies and do not advance any screw morethan 1/2 turn during final tightening. Over-tightening maystrip bone and compromise fixation of the implant in vertebral bodies.

1

2

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Implant Removal

If a Zero-P VA implant must be removed, the following technique is recommended.

1Remove screws

Instruments

03.617.904 Screw Inserter, T8, self-retaining, quickcoupling

03.647.903 Handle with quick coupling, small

03.647.985 Screw Removal Blade

Attach the handle to the screw inserter, then engage the assembled driver into the first screw to be removed. Engagea tip of the screw removal blade into the blocking mechanismof the interbody plate corresponding to screw to be removed.While pressing the blocking mechanism toward midline withthe removal blade, turn the assembled driver counterclockwiseto remove the screw.

Repeat with the second screw.

Note: If the blocking mechanism is initially difficult to depress towards the midline, it may be binding on the head of the screw. In such cases, advance the screw 1⁄4 turnclockwise before continuing with screw removal.

Zero-P VA Instruments and Implants Technique Guide Synthes 29

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Implant Removal

Alternative technique: Using the removal screwdriver

Instrument

03.647.971 Removal Screwdriver

Engage the tip of the removal screwdriver in the drive recessof the first screw to be removed. Turn the top knob of the removal driver (engraved “1”) counterclockwise until the topknob is flush with the middle section (“engraved “3”); thisfully engages the inner shaft into the screw.

Lower the outer sleeve of the removal driver (engraved “2”)by turning clockwise until the sleeve retracts the blockingmechanism in the interbody plate. Finally, turn the middlesection (engraved “3”) counterclockwise to remove the screw.

Repeat with the second screw.

Caution– If the inner shaft is not fully engaged prior to attempting subsequent screw removal technique steps, breakage of the driver may occur and could potentially harm the patient.– The removal screwdriver should only be used for screw removal; use of the removal screwdriver for screw insertion may lead to driver and/or implant breakage.

Note: If the blocking mechanism is initially difficult to depress towards the midline, it may be binding on the head of the screw. In such cases, advance the screw 1⁄4 turnclockwise before continuing with screw removal.

30 Synthes Zero-P VA Instruments and Implants Technique Guide

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2Extract Implant

Instrument

03.647.963 Insertion Device, for Zero-P VA

Once the screws are removed, remove the Zero-P VA implantusing the insertion device. Engage the insertion device to theimplant by first aligning the recessed grooves located midlineon the anterior face of the implant with the pronged tabs ofthe device tip.

Zero-P VA Instruments and Implants Technique Guide Synthes 31

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Zero-P VA Titanium Cervical Spine Screws– Self-tapping or self-drilling options– Titanium alloy (Ti-6Al-7Nb)– Color-coded by screw length

Implants

Zero-P VA Implants– Supplied sterile and preassembled (spacer with interbody

plate)– Available in 3 different shapes: convex, lordotic, parallel– Spacer component: PEEK Optima – Interbody plate component: Titanium alloy (Ti-6Al-7Nb

and Ti-6Al-4V)– Blocking mechanism: Titanium alloy (Ti-6Al-4V, Elgiloy

(40Co-20Cr-16FE-15Ni-7Mo)

32 Synthes Zero-P VA Instruments and Implants Technique Guide

* Also available

Height (mm) Convex Lordotic Parallel

5 04.647.135S 04.647.125S 04.647.115S

6 04.647.136S 04.647.126S 04.647.116S

7 04.647.137S 04.647.127S 04.647.117S

8 04.647.138S 04.647.128S 04.647.118S

9 04.647.139S 04.647.129S 04.647.119S

10 04.647.130S 04.647.120S 04.647.110S

11 04.647.131S* 04.647.121S* 04.647.111S*

12 04.647.132S* 04.647.122S* 04.647.112S*

Length (mm) Color Self-Drilling Self-Tapping

12 ■ – 04.647.872

14 ■ 04.647.834 04.647.874

16 ■ 04.647.836 04.647.876

18 ■ – 04.647.878

Note: Screws are provided non-sterile

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Instruments

03.617.900 Angled StarDrive Screwdriver, T8, with sleeve, self-retaining

03.617.904 Screw Inserter, T8, self-retaining, quick coupling

2.0 mm Drill Bits, quick coupling03.617.912 with 12 mm stop03.617.914 with 14 mm stop03.617.916 with 16 mm stop

03.617.981 Impactor, flat

03.647.720– Zero-P VA Trial Spacers with stop, 03.647.729 parallel 5–12 mm heights

03.647.750– Zero-P VA Trial Spacers with stop,03.647.759 lordotic 5–12 mm heights

03.647.780– Zero-P VA Trial Spacers with stop, 03.647.789 convex 5–12 mm heights

Zero-P VA Instruments and Implants Technique Guide Synthes 33

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Instruments

03.647.901 Holding Sleeve, for StarDrive ScrewdriverShaft

03.647.903 Handle with quick coupling, small

03.647.964 Drill Guide with handle, variable angle

03.647.963 Insertion Device, for Zero-P VA

03.647.970 Cancellous Bone Impactor

03.647.971 Removal Screwdriver

34 Synthes Zero-P VA Instruments and Implants Technique Guide

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03.647.972 Inner Shaft for Removal Screwdriver

03.647.980 Implant Holder, for Zero-P VA

03.647.982 Impactor, ball tip

03.647.984 Packing Block, for Zero-P VA

03.647.985 Screw Removal Blade

03.647.993 2.5 mm Angled Awl

03.647.994 2.5 mm Awl with sleeve, for variable angleinsertion

03.820.113 Slotted Mallet

Zero-P VA Instruments and Implants Technique Guide Synthes 35

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Instrument Disassembly

1

36 Synthes Zero-P VA Instruments and Implants Technique Guide

03.617.900 Angled Screwdriver, T8, with sleeve, self-retaining

2

3 4

03.647.994 2.5 mm Awl with sleeve

21

1

1

2

2

1

2

Lubricate with oil

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Zero-P VA Instruments and Implants Technique Guide Synthes 37

03.647.901 Holding Sleeve, for StarDrive Screwdriver Shaft

03.647.971 Removal Screw Driver

1 2

4

1

2

3

2

3 4

Lubricate with oil

1

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Zero-P VA Instrument and Titanium Screw Set (01.647.040)

38 Synthes Zero-P VA Instruments and Implants Technique Guide

Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to http://www.synthes.com/sites/NA/MedicalCommunity/Pages/Cleaning_and_Sterilization.aspxor to the below listed inserts, which will be included in the shipping container: – Processing Synthes Reusable Medical Devices - Instruments, Instrument Trays

and Graphic Cases—DJ1305 – Processing Non-sterile Synthes Implants—DJ1304

Graphic Case

60.647.001 Graphic Case, for Zero-P VA Instrumentand Implant Set

Modules

60.647.002 Module, for 3.7mm Titanium Zero-P VAScrews

60.647.003 Module, for Trial Implants(These modules are included in 60.647.001)

Instruments

03.617.900 Angled StarDrive Screwdriver, T8, with sleeve, self-retaining

03.617.904 Screw Inserter, T8, self-retaining, quick coupling, 2 ea.

03.617.912 2.0 mm Drill Bit with 12 mm stop, quick coupling, 2 ea.

03.617.914 2.0 mm Drill Bit with 14 mm stop, quick coupling, 2 ea.

03.617.916 2.0 mm Drill Bit with 16 mm stop, quick coupling, 2 ea.

03.617.981 Impactor, flat

03.647.901 Holding Sleeve, for StarDrive screw inserter, T8, 2 ea.

03.647.903 Handle with quick coupling, small, 2 ea.

03.647.963 Insertion Device, for Zero-P VA

03.647.964 Drill Guide with handle, variable angle

03.647.970 Cancellous Bone Impactor

03.647.971 Removal Screwdriver

03.647.972 Inner Shaft for Removal Screwdriver

03.647.980 Implant Holder, for Zero-P VA

03.647.982 Impactor, ball tip

03.647.984 Packing Block, for Zero-P VA

03.647.985 Screw Removal Blade

60.647.001

Lower tray

Middle tray

Top tray

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Zero-P VA Instruments and Implants Technique Guide Synthes 39

03.647.993 2.5 mm Angled Awl

03.647.994 2.5 mm Awl with sleeve, for variable angleinsertion

03.820.113 Slotted Mallet

Implants

3.7 mm Titanium Cervical Spine Screws,variable angle, 6 ea.

04.647.834 Self-drilling, 14 mm

04.647.836 Self-drilling, 16 mm

04.647.872 Self-tapping, 12 mm

04.647.874 Self-tapping, 14 mm

04.647.876 Self-tapping, 16 mm

04.647.878 Self-tapping, 18 mm

Carry case

60.647.003

60.617.903

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40 Synthes Zero-P VA Instruments and Implants Technique Guide

Zero-P VA Trial Spacer and Implant Sets

Zero-P VA Parallel Trial Spacer with Stops Set(01.647.041) Zero-P VA Trial Spacers with stop, parallel

03.647.725 5 mm height

03.647.726 6 mm height

03.647.727 7 mm height

03.647.728 8 mm height

03.647.729 9 mm height

03.647.720 10 mm height

60.617.903 Trial Spacer Tray

Zero-P VA Lordotic Trial Spacer with Stops Set(01.647.042) Zero-P VA Trial Spacers with stop, lordotic

03.647.755 5 mm height

03.647.756 6 mm height

03.647.757 7 mm height

03.647.758 8 mm height

03.647.759 9 mm height

03.647.750 10 mm height

60.617.903 Trial Spacer Tray

Zero-P VA Convex Trial Spacer with Stops Set(01.647.043) Zero-P VA Trial Spacers with stop, convex

03.647.785 5 mm height

03.647.786 6 mm height

03.647.787 7 mm height

03.647.788 8 mm height

03.647.789 9 mm height

03.647.780 10 mm height

60.617.903 Trial Spacer Tray

Zero-P VA Parallel Implant Set (01.647.044) Zero-P VA Implants, parallel, sterile

04.647.115S 5 mm height, 1 ea

04.647.116S 6 mm height, 2 ea

04.647.117S 7 mm height, 3 ea

04.647.118S 8 mm height, 3 ea

04.647.119S 9 mm height, 2 ea

04.647.110S 10 mm height, 1 ea

60.647.004 Carry Case, for Zero-P Implants

Zero-P VA Lordotic Implant Set (01.647.045) Zero-P VA Implants, lordotic, sterile

04.647.125S 5 mm height, 1 ea

04.647.126S 6 mm height, 2 ea

04.647.127S 7 mm height, 3 ea

04.647.128S 8 mm height, 3 ea

04.647.129S 9 mm height, 2 ea

04.647.120S 10 mm height, 1 ea

60.647.004 Carry Case, for Zero-P Implants

Zero-P VA Convex Implant Set (01.647.046) Zero-P VA Implants, convex, sterile

04.647.135S 5 mm height, 1 ea

04.647.136S 6 mm height, 2 ea

04.647.137S 7 mm height, 3 ea

04.647.138S 8 mm height, 3 ea

04.647.139S 9 mm height, 2 ea

04.647.130S 10 mm height, 1 ea

60.647.004 Carry Case, for Zero-P Implants

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Zero-P VA Instruments and Implants Technique Guide Synthes 41

Also Available

314.467 StarDrive Screwdriver Shaft, T8, 105mm

03.617.902 StarDrive Screwdriver Shaft, T8,self-retaining

03.617.930 Extension Shaft, 115mm

03.617.940 Handle, with large quick coupling

03.617.971S* Conical Extraction Screw

03.617.975S* 2.0 mm Drill Bit for Conical Extractionscrew

03.647.962 Drill Guide with handle, nominal angle

03.647.990 2.5 mm Awl with sleeve, for nominal angleinsertion

03.647.721 Zero-P VA Trial Spacer with stop, parallel,11 mm height

03.647.722 Zero-P VA Trial Spacer with stop, parallel,12 mm height

03.647.751 Zero-P VA Trial Spacer with stop, lordotic,11 mm height

03.647.752 Zero-P VA Trial Spacer with stop, lordotic,12 mm height

03.647.781 Zero-P VA Trial Spacer with stop, convex,11 mm height

03.647.782 Zero-P VA Trial Spacer with stop, convex,12 mm height

04.647.111S Zero-P VA Implant, parallel, 11 mm height,sterile

04.647.112S Zero-P VA Implant, parallel, 12 mm height,sterile

04.647.121S Zero-P VA Implant, lordotic, 11 mm height,sterile

04.647.122S Zero-P VA Implant, lordotic, 12 mm height,sterile

04.647.131S Zero-P VA Implant, convex, 11 mm height,sterile

04.647.132S Zero-P VA Implant, convex, 12 mm height,sterile

60.647.010 Label Sheet for Zero-P VA Trial Spacer Tray

60.647.011 ID Card for Zero-P product family implantcarry case

60.647.012 Label Sheet for Zero-P product familyimplant carry case

60.647.013 Zero-P carry case contents card

*Refer to Zero-P Technique Guide (J8566) for instructions for use.

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Bibliography

1. Kaiser MG, RW Haid Jr., BR Suback, et al. 2002. “Anteriorcervical plating enhances arthrodesis after discectomy andfusion with cortical allograft.” Neurosurgery 50: 229-236.

2. Caspar W, FH Geisler, T Pitzen, et al. 1998. “Anterior Cervical plate stabilization in one and two level degenerativedisease: overtreatment or benefit?” J. Spinal Disord. 11:1-11.

3. Mobbs RJ, P Rao and NK Chandran. 2007. “Anterior cervicaldiscectomy and fusion: analysis of surgical outcome withand without plating.” J. Clin. Neurosci. 14:639-642.

4. Moftakhar R and GR Trost. 2004. “Anterior cervical plates:a historical perspective.” Neurosurg. Focus. 16:E8.

5. Park JB, YS Cho and KD Riew. 2005. “Development of adjacent-level ossification in patients with an anterior cervical plate.” J. Bone Joint Surg. Am. 87:558-563.

6. Müller ME, M Allgöwer, R Schneider, and H Willenegger.Manual of Internal Fixation, 3rd edition. Berlin: Springer-Verlag. 1991.

7. Ibid.

42 Synthes Zero-P VA Instruments and Implants Technique Guide

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Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185

© 2011 Synthes, Inc. or its affiliates. All rights reserved. Zero-P and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 2/12 J9912-B

www.synthes.com

Synthes USA1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056