Surgical Technique - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes... · Designed to guide and turn the cage into the desired position Pyramidal teeth Designed

Transforaminal Posterior Atraumatic Lumbar Cage System Available in PEEK, Titanium and ProTi 360°™ Titanium Integrated Technology

T-PAL™ Interbody SystemSurgical Technique

Image intensifier control

This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

T-PAL™ Interbody System Surgical Technique DePuy Synthes 1

Table of Contents

Introduction T-PAL 2

AO Spine Principles 4

Indications and Contraindications 5

Surgical Technique Preoperative Planning and Preparation 6

Patient Positioning 7

Access and Exposure 8 – Minimally invasive transforaminal approach 8 – Open transforaminal approach 10

Discectomy 11

Disc Space Preparation 12

Trial for Implant Size 13

Implant Preparation 23

PEEK & ProTi 360˚™ Implant Insertion 26

Titanium Implant Insertion 30

Posterior Support 34

Implant Removal 35

Product Information Implants 37

Instruments 39

Sets 43

Applicator Instructions 45

Function control 48

Filling Material 49

2 DePuy Synthes T-PAL™ Interbody System Surgical Technique

• Rails on top of the implant, designed to guide and turn the cage between the vertebral bodies into the desired position

• Three x-ray markers help to visualize the implant under radiographic control• Cages available in three material types PEEK, Titanium & ProTi 360°™ Titanium Technology Integrated.

T-PAL Interbody System

Implant with guiding rails

Material• PEEK (Titanium alloy marker pins (TAN - Ti-6Al-7Nb)• Titanium alloy (TAN - Ti6Al-7Nb)• ProTi 360° PEEK Titanium Integrated (Tantalum pins)

Two anterior radiographic marker pinsEnable visualization of the anterior implant positionThe PEEK Cages 1.4 mm diameter pins and ProTi 360° 1 mm diameter pins are approximately 2 mm from the anterior edge of the implant.

Radiographic marker pinEnable visualization of implant tip position during insertion

Connection cylinderPermits the pivoting mechanism in combination with the applicator

Axial windowAccommodates autogenous bone graft or bone graft substitute to allow fusion to occur through the cage

Rails on the surfaceDesigned to guide and turn the cage into the desired position

Pyramidal teethDesigned to provide resistance to implant migration

Self-distracting noseAllows for ease of insertion

Lordotic angle5° (except for the 7 mm height)

The 1.4 mm diameter, 5mm long pin is located in the middle of the cage and stops at the bullet nose tip of the cage. A 1 mm diameter, 3 mm long pin is represented in T-PAL ProTi 360˚ cage.


AP trial marker Lateral trial marker

• Trial implants can be placed at the same position, where after the implant will be placed

• Designed for guided insertion, which is facilitated by the pivoting applicator and the rails on the surface of the implants and trials

• Insertion technique based on one key instrument: the applicator

Guided insertion technique

• One key instrument for insertion of implant and trials

• Applicator is designed to allow a controlled and guided insertion based on the pivoting option

• Security button designed to prevent implant disengagement

• Applicator is designed for minimally invasive surgeries

One surgery, one instrument


coronalaxial

sagittal

The four principles to be considered as the foundation for proper spine patient management underpin the design and delivery of the Curriculum: Stability – Alignment – Biology – Function.1,2

StabilityStabilization to achieve a specific therapeutic outcome

BiologyEtiology, pathogenesis, neural protection, and tissue healing

AlignmentBalancing the spine in three dimensions

FunctionPreservations and resto-ration of function to prevent disability

AO Spine Principles

Copyright © 2012 by AOSpine

1 Aebi et al (1998)2 Aebi et al (2007)


Indications and Contraindications

Intended useThe T-PAL implant is intended to replace lumbar inter vertebral discs and to fuse the adjacent vertebral bodies together at vertebral levels L1–S1. The T-PAL implant is designed for a transforaminal approach.

IndicationsIndications are lumbar and lumbosacral pathologies in which segmental spondylodesis is indicated, for example:• Degenerative disc diseases and spinal instabilities• Revision procedures for post-discectomy syndrome• Pseudarthrosis or failed spondylodesis• Degenerative spondylolisthesis• Isthmic spondylolisthesis

Contraindications• Vertebral body fractures• Spinal tumours• Major spinal instabilities• Primary spinal deformities• Osteoporosis

Warning: T-PAL must be applied in combination with posterior fixation.

Note : ProTi 360° please refer to the corresponding Instructions for Use for specific information on its use, indications, contraindications, precautions, warnings and side effects.

T-PAL PEEK and Titanium Implants


Preparation

Set

01.812.001 Set T-PAL

Optional sets

01.809.011 Dilation Instrument Set

01.615.004 Insight Tubes Set or 01.615.002 Insight Retractor Set,

Standard Configuration

01.612.110 Set for MIS Support System

01.605.903 Set for Minimally Invasive Posterior Instruments

Have all necessary imaging studies readily available to plan implant placement and visualize individual patient anatomy.

Have all sets readily available prior to surgery.

Preoperative Planning and Preparation


Position the patient

Position the patient in a restored physiological lordosis, avoiding abdominal restriction to reduce venous stasis.

Patient Positioning


1. Approach

Optional sets


01.615.004 Insight Tubes Set or 01.615.002 Insight Retractor Set,

Standard Configuration

01.612.110 MIS Support System Set

Locate the correct operative level with fluoroscopic views. Push the Kirschner wire into the desired facet joint. Separate the posterior soft tissue by inserting the smallest diameter dilator over the Kirschner wire. Repeat with next larger diameter dilator until required dilation is achieved. Use fluoroscopy to determine the location of dilator.

Access and Exposure Minimally invasive transforaminal approach

2a. Retraction with Insight tubes

Instrument set

01.615.004 Insight Tubes Set

Optional sets



Determine the appropriate tube length from the depth indicators on the dilators.

Slide the tube over the dilators until it contacts the facet joint.

Use the Flex Arm to stabilize the tube to the OR table. Remove the dilators and the Kirschner wire.


2b. Retraction with Insight retractor

Instrument set

01.615.002 Insight Retractor Set, Standard Configuration

Optional Sets



Determine the appropriate retractor lengths of the cranial/caudal and medial/lateral blades from the depth indicators on the dilators.

Slide the retractor with the cranial/caudal blades over the dilators until the blades contact the facet joints. Distract the blades and introduce the second retractor with the medial/lateral blades.

Use the Flex Arm to stabilize the retractor to the OR table. Remove the dilators and the Kirschner wire.

3. Cut transforaminal window

Instruments

03.605.508 Osteotome, straight, black

03.605.520 Laminectomy Punch, 40°, 4.0 mm, black

Prepare a window for the transforaminal approach using the osteotome to remove the inferior facet of the cranial vertebra and the superior facet of the caudal vertebra.

With the punch, additional bone or osteophytes can be removed.


1. Retraction with an open transforaminal approach

Instrument

03.812.040 Lamina Spreader for T-PAL

Make a standard open incision, retract the muscle layer to view the desired segment.

Distract the segment if desired. Position the lamina spreader for T-PAL at the base of the spinous processes. Distract carefully until required distraction is achieved.

Distraction opens the posterior disc space and promotes exposure both for decompression and delivery of the implant.

2. Cut transforaminal window

Instruments



Prepare a window for the transforaminal approach using the osteotome to remove the inferior facet of the cranial vertebra and the superior facet of the caudal vertebra.

With the laminectomy punch, additional bone or osteophytes can be removed.

Access and Exposure

Open transforaminal approach


Instruments

03.605.507 Rasp, dual-sided, bayoneted, black

03.605.510 Ring Curette, straight, bayoneted, black

03.605.514 Rongeur, curved, 4.0 mm, black


03.605.527 Rongeur, straight, 4.0 mm, black

03.605.529 Curette, rectangular, angled, right, bayoneted, black

03.605.530 Curette, rectangular, angled, left, bayoneted, black

03.803.054 Curette, rectangular, bayoneted, black

389.767– Shaver for Intervertebral Discs, 389.777 size 7–17 mm

394.951 T-Handle with Quick Coupling

Through an incision above the pedicle, access the foramen and remove disc material, using any of the following instruments: box and ring curettes, rongeurs as well as disc shavers.

The annulus must be preserved to provide additional support for the T-PAL implant and prevent migration of bone graft and bone graft substitute into the spinal canal.

The shavers can initially be used to ream out disc m aterial or for final removal of the disc material and cartilaginous tissue.

For removal of the tissue in the far lateral disc space, use the left/right angled curettes and the curved rongeur.

Warning: Provide enough lateral exposure to the disc to reduce dural retraction.

Discectomy


1. Prepare endplates

Instrument

03.605.511 Rasp, dual-sided, angled, bayoneted, black

When the discectomy is completed, use the rasp to remove the superficial cartilaginous layers of the endplates to expose the bleeding bone.

Warning: Excessive removal of the subchondral bone may weaken the vertebral endplate. The entire removal of the endplate may result in subsidence and a loss of segmental stability.

Disc Space Preparation

2. Pack disc space

Instrument

03.605.532 Impactor, curved, standard, bayoneted, black

Before the T-PAL cage is implanted, the anterior and far lateral disc space should be filled with bone graft or bone graft substitute.

Note: For more information about the filling material chronOS see page 49.


1

2

3

Trial for Implant Size

1. Assemble applicator and connect non detachable trial implant

Instruments

03.812.001 Applicator Outer Shaft

03.812.307– T-PAL Small Trial Implant, size 7–17 mm, 03.812.317 non detachable

03.812.507– T-PAL Large Trial Implant, size 7–17 mm, 03.812.517 non detachable

03.812.004 Applicator Knob

The applicator must be assembled before insertion of the trial.

Attach the applicator knob to the proximal end of the applicator outer shaft by turning the knob counterclockwise until it stops (1).

Select an appropriately size trial implant. Insert the trial implant shaft into the applicator outer shaft making sure that the arrow on the outer shaft is aligned with the distal opening of the trial implant shaft (2). The trial implant shaft should now be trapped inside the applicator outer shaft (3).

Turn the applicator knob clockwise to secure the trial implant. During this attaching procedure the security ring moves upwards, so that the green color band is visible. Continue to turn the knob until it is tightened.

Warning: Ensure the arrows on the end of the applicator align with those on the trial implant. The contact surfaces between the trial and the applicator should have no gap (3).

Note: For disassembly pull the security ring down, turn the applicator knob counterclockwise until it stops. Push the small button on the applicator knob and simultaneously pull the trial implant shaft out of the applicator outer shaft. Turn the applicator knob clockwise. For detailed disassembly instructions please refer to page 47.

Warning: Please read first the applicator instruc-tions on page 45 - 46.


1

2

3


Optional: Assemble applicator and connect detachable trial implant

Instruments


03.812.003 Applicator Inner Shaft


The applicator must be assembled before insertion of the trial.

Attach the applicator knob to the proximal end of the applicator outer shaft by turning the knob counterclockwise until it stops (1).

Insert the applicator inner shaft into the applicator outer shaft making sure that the arrow on the outer shaft is aligned with the distal opening of the inner shaft (2). The applicator inner shaft should now be trapped inside the outer shaft (3).

Note: For disassembly pull the security ring down, turn the applicator knob counterclockwise until it stops. Push the small button on the applicator knob and simultaneously pull the inner shaft out of the outer shaft. Turn the applicator knob clockwise. For detailed disassembly instructions please refer to page 47.

Warning: Please read the applicator instructions on page 45-46.


1 2

3

Connect detachable trial implant to the applicator

Instruments

03.812.007– T-PAL Small Trial Implant, size 7–17 mm 03.812.017

03.812.207– T-PAL Large Trial Implant, size 7–17 mm 03.812.217

Connect an appropriately sized trial implant to the applicator. Pull the security ring down and simultaneously turn the knob at the proximal end of the applicator counterclockwise. The applicator jaws open (1). Place the jaws over the proximal end of the trial implant making sure to align the arrows on the end of the applicator with those on the trial implant (2).

Turn the applicator knob clockwise to close the jaws. During this closing procedure the security ring moves upwards, so that the green color band is visible (3). Continue to turn the knob until it is tightened (2).

Notes: When the applicator knob remains tightened, the trial implant cannot pivot or detach.

Warning: Ensure the arrows on the end of the applicator align with those on the trial implant. The contact surfaces between the trial implant and the applicator should have no gap (2).


10–15°

1

2

3


2. Insert trial implant

Optional instrument

SFW691R Prodisc-L Combined Hammer

Recheck the firm connection of trial implant to applicator. Insert the trial implant into the disc space, ensuring that the orientation of the trial implant is correct. The trial implant tip should be orientated medial. Maintain 10–15° between the applicator handle and the sagittal plane during trial implant insertion (1).Controlled and light hammering on the applicator may be required to advance the trial implant into the intervertebral disc space. Use fluoroscopy to confirm position and fit of the trial implant. The tip should be positioned near the anterior edge of the adjacent vertebral bodies (2).

Notes:• Firm connection of trial implant to applicator can

be checked manually by applying pressure on the lateral side of the trial implant with the thumb. Trial implant should not pivot.

• Use soft tissue retractor 389.857–389.859 to protect soft tissue.

• Use fluoroscopy during the insertion to confirm anterior positioning of the trial implant.

Warnings:• The trial tip indicates approximate final anterior

position of the trial implant (3). • Maintain 10–15° between the applicator handle

and the sagittal plane during trial implant insertion.


10–15°

10–15°

2

13. Position trial implant

Optional Instrument


Turn the applicator knob counterclockwise until it stops (1)

Precaution: Ensure applicator knob is turned counterclockwise until it stops to avoid trial or applicator outershaft deformation.

Controlled and light hammering on the applicator may be required to pivot the trial implant into final position (2).

Use fluoroscopy during the pivoting procedure and confirm fit and position of the trial implant. Each trial has a medial/lateral and an anterior/posterior opening for position control. If the trial implant appears too small or too tight, try the next larger or smaller size height until the most secure fit is achieved.

Notes: • Ensure that the trial implant is positioned where

the implant will be placed.

Warnings: • Maintain 10–15° between the applicator handle

and the sagittal plane during trial implant insertion.

• Do not detach the trial implant in the disc space.


1

10–15°

2

1Optional: Position trial implant

If trial implant does not pivot automatically, turn the applicator handle medially to initiate pivoting upon impaction (1). After pivoting is initiated the applicator handle must be turned back to an angle of 10–15° from the sagittal plane to pivot the trial implant into final position (2).

Warning: Maintain 10–15° between the applicator handle and the sagittal plane for final trial implant insertion.



1 24. Remove non detachable

trial implant

Instruments

03.809.972 Oracle Slide Hammer

Optional instrument


Warning: The applicator must be in the pivoting position to remove the trial implant.

Slide the slide hammer onto the end of the applicator knob with quick coupling (1). While holding the handle with one hand, apply an upward force to the slide hammer with the other hand. Repeat this procedure until the trial implant is removed (2).

Optionally the combination hammer may also be used to remove the trial implant.

Remove the slide hammer from the handle by pushing on the end of the slide hammer.


43

5


To detach the trial implant from the applicator pull the security ring down simultaneously turn the knob counterclockwise until it stops (3). Push the small button on the applicator knob and remove the trial implant (4).

Insert the applicator inner shaft into the applicator outer shaft making sure that the arrow on the outer shaft is aligned with the distal opening of the inner shaft (5). The applicator inner shaft should now be trapped inside the outer shaft. The applicator is now ready to accept the implant.

Note: If the security ring cannot be pulled down, turn the knob clockwise a quarter turn. The ring can now be pulled down.


1 2Optional: Remove detachable trial implant

Instrument


Optional instrument


Warning: The applicator must be in the pivoting position to remove the trial implant.

Note: Please refer to page 45 for pivoting positioningSlide the slide hammer onto the end of the applicator knob with quick coupling (1). While holding the handle with one hand, apply an upward force to the slide hammer with the other hand. Repeat this procedure until the trial implant is removed (2).

Optionally the combination hammer may also be used to remove the trial implant.

Remove the slide hammer from the handle by pushing on the end of the slide hammer.


3 43


To detach the trial implant, pull the security ring down and simultaneously turn the applicator knob counterclockwise until it stops (3). The trial implant can now be removed from the applicator (4).



Implant Preparation

1. Select Implant

Implants and Instruments

08.812.007S– T-PAL Small, Cage, height 7–17 mm, 08.812.017S PEEK, sterile

08.812.207S– T-PAL Large, Cage, height 7–17 mm, 08.812.217S PEEK, sterile

04.812.007S– T-PAL Small, Cage, height 7–17 mm, 04.812.017S Titanium, sterile

04.812.207S– T-PAL Large, Cage, height 7–17 mm, 04.812.217S Titanium, sterile

108812007– T-PAL ProTi 360˚ Small, cage, 108812015 height 7-15mm, sterile

108812207– T-PAL ProTi 360˚ Large, cage, 108812215 height 7-15mm, sterile

03.812.044 Packing Block for T-PAL

Select the T-PAL implant that corresponds to the height and size measured using the trial implant in the previous steps.

Insert the selected implant into the appropriate packing block place.

Note: Cages available in three material types PEEK, Titanium & the ProTi 360° PEEK TitaniumIntegrated.


1

2

3

2. Pack implant

Instrument

03.812.043 Cancellous Bone Impactor for T-PAL

Turn the packing block on its side and use the cancellous bone impactor to firmly pack the filling material into the implant cavities (1).

Make sure the implant is well placed in the packing block to avoid implant damage while bone graft filling (2).

It is important to fill the implant until the filling material protrudes from its perforations in order to ensure optimal contact with the vertebral endplates (3).

For more information about the graft filling volumes, see page 37 in this surgical technique.

Note: For more information about the filling mate rial chronOS see page 49.

Implant Preparation


1

3

23. Connect implant to the applicator

Instruments




To connect the implant to the applicator turn the packing block upwards again. Pull the security ring down and simultaneously turn the knob at the proximal end of the applicator counterclockwise. The applicator jaws open (1). Place the jaws over the proximal end of the implant making sure to align the arrows on the end of the applicator with those on the implant (2).

Turn the applicator knob clockwise to close the jaws. During this closing procedure the security ring moves upwards, so that the green color band is visible. Continue to turn the knob until it is tightened (3).

Note: When the applicator knob is tightened, the implant cannot pivot or detach.

Warning: Ensure the arrows on the end of the applicator align with those on the implant. The contact surfaces between the implant and the applicator should have no gap (2).


10–15°

1

2

3

1. Insert implant

Optional Instrument


Recheck the firm connection of implant to applicator. Insert the implant into the disc space, ensuring that the orientation of the implant is correct. The implant tip should be orientated medial. Maintain 10–15° between the applicator handle and the sagittal plane during implant insertion (1). Controlled and light hammering on the applicator may be required to advance the implant into the intervertebral disc space.Use fluoroscopy to confirm position and fit of the implant.The tip should be positioned near the anterior edge of the adjacent vertebral bodies (2).

Notes: • Firm connection of implant to applicator can be

checked manually by applying pressure on the lateral side of the implant with the thumb. Implant should not pivot.

• Use soft tissue retractor 389.857–389.859 to reduce soft tissue damage/injury.

• Use fluoroscopy during the insertion to confirm anterior position of the implant.

• The anterior marker pins of the implant are located approximately 2 mm from the edge of the implant.

Warnings:• The implant tip marker pin indicates approximate

final anterior position of implant (3).• Maintain 10–15° between the applicator handle

and the sagittal plane during implant insertion.

PEEK and ProTi 360˚ Implant Insertion


10–15°

10–15°1

2

2. Position implant

Optional Instrument


Turn the applicator knob counterclockwise until it stops (1).

Note: Ensure applicator knob is turned counterclockwise until it stops to avoid deformation of the applicator outershaft.

Controlled and light hammering on the applicator may be required to pivot the implant into final position (2). Use fluoroscopy during the pivoting procedure and confirm fit and position of the implant. With a medial/lateral fluoroscopic image of the cage in the final position, the two anterior pins of the implant should appear as one line.

In an anterior/posterior fluoroscopic image, the two anterior pins should be equidistant to the pedicles. The tip pin indicates the lateral edge of the implant.

Notes: If bone graft or bone graft substitutes are pla-ced into the disc space after trialing, the implant may not reach the same position as the trial.

Warning: Maintain 10–15° between the applicator handle and the sagittal plane during implant insertion.


10–15°

1 2

Optional: Position implant

If implant does not pivot automatically, turn the applicator handle medially to initiate pivoting upon impaction (1). After pivoting is initiated the applicator handle must be turned back to an angle of 10–15° from the sagittal plane to pivot the implant into final position (2).

Warning: Maintain 10–15° between the applicator handle and the sagittal plane for final implant insertion.

PEEK and ProTi 360° Implant Insertion


3. Detach implant

To detach the implant, pull the security ring down and simultaneously turn the applicator knob counterclockwise until it stops. The applicator can now be removed from the implant.

Use fluoroscopy to verify final position of the implant. With a medial/lateral fluoroscopic image, the two anterior pins of the implant should appear as one line and the tip marker as a dot.

Notes: • If the security ring cannot be pulled down, turn

the knob clockwise a quarter turn. The ring can now be pulled down.

• If the applicator does not disengage from the implant move the applicator handle laterally to free the instrument.


10–15°

2

3

Titanium Implant Insertion

1. Insert implant

Optional instrument


Recheck the firm connection of implant to applicator. Insert the implant into the disc space, ensuring that the orientation of the implant is correct. The implant tip should be orientated medial. Maintain 10–15° between the applicator handle and the sagittal plane during implant insertion (1). Controlled and light hammering on the applicator may be required to advance the implant into the intervertebral disc space.Use fluoroscopy to confirm position and fit of the implant. The tip should be positioned near the anterior edge of the adjacent vertebral bodies (2).

Notes:• Firm connection of implant to applicator can be

checked manually by applying pressure on the lateral side of the implant with the thumb. Implant should not pivot.

• Use soft tissue retractor 389.857–389.859 to protect soft tissue.

• Use fluoroscopy during the insertion to confirm anterior position of the implant.

Warnings: • The implant tip indicates approximate final

anterior position of the implant (3).• Maintain 10–15° between the applicator handle

and the sagittal plane during implant insertion.


10–15°

10–15°

1

2

2. Position implant

Optional instrument


Turn the applicator knob counterclockwise until it stops (1).

Note: Ensure applicator knob is turned counterclockwise until it stops to avoid deformation of the applicator outershaft.

Controlled and light hammering on the applicator may be required to pivot the implant into final position (2). Use fluoroscopy during the pivoting procedure and confirm fit and position of the implant. Each implant has a medial/lateral and an anterior/posterior opening for position control.

Notes: • If bone graft or bone graft substitutes are placed

into the disc space after trialing, the implant may not reach the same position as the trial.

Warning: Maintain 10–15° between the applicator handle and the sagittal plane during implant insertion.


10–15°

1 2

Optional: Position implant

If implant does not pivot automatically, turn the applicator handle medially to initiate pivoting upon impaction (1). After pivoting is initiated the applicator handle must be turned back to an angle of 10–15° from the sagittal plane to pivot the implant into final position (2).

Warning: Maintain 10–15° between the applicator handle and the sagittal plane for final implant insertion.

Titanium Implant Insertion


3. Detach implant

To detach the implant, pull the security ring down and simultaneously turn the applicator knob counterclockwise until it stops. The applicator can now be removed from the implant.

Use fluoroscopy to verify final position of the implant. With a medial/lateral fluoroscopic image, lateral opening of the titanium T-PAL implant should be visible.

Notes: • If the security ring cannot be pulled down, turn

the knob clockwise a quarter turn. The ring can now be pulled down.

• If the applicator does not disengage from the implant move the applicator handle laterally to free the instrument.


1. Pack disc space

Instrument


After the T-PAL cage is implanted, fill the posterior disc space and the lateral disc space with bone graft or bone graft substitute to create desired conditions for fusion.

Note: For more information about the filling mate-rial chronOS see page 49.

Posterior Support

2. Supplemental fixation

The T-PAL cage is intended to be used in combination with posterior fixation.


Implant Removal

Implant removal with the applicator

Instruments




Ensure that the applicator is in the fully open position. Locate the implant and close the applicator by turning the knob clockwise until the security ring is moving upwards. There should be no gap between the applicator knob and the security ring. To ensure that the knob is in contact with the security ring, turn the knob counterclockwise until it stops, in this position the implant can pivot but not detach from the ap plicator. The implant can now be removed. The slap hammer may be required to facilitate removal.

Note: Distraction of the segment may facilitate implant removal. However, if possible, do not distract before ensuring a firm connection between the implant and the applicator.

Warning: The applicator must be in the pivoting position to remove the implant.


Implant Removal

Implant removal with the removal tool

Instrument

03.812.005 Removal Tool for T-PAL

Optional instrument


Ensure that the removal tool for T-PAL is in the fully open position. Locate the implant and squeeze the handle firmly. Advance the speed nut to lock the handle. The implant can now be removed. The slide hammer may be required to facilitate removal.

Notes: • When the removal tool handle is squeezed,

the implant can pivot but not detach from the removal tool.

• Distraction of the segment may facilitate implant removal. However, if possible, do not distract before ensuring a firm connection between the implant and the removal tool.


Implants

Graft volume

The table below shows the approximate graft volume that T-PAL implants will hold, depending on the footprint and heights.

Anterior

Posterior

Total depthSmall implants14 mmLarge implants16 mm

Insertion depthSmall implants 10 mmLarge implants 12 mm

LengthSmall implants 28 mmLarge implants 32 mm

* 7 mm height = 0°

T-PAL Implant, 5° angle*, small footprint 10 × 28 mm

Heights Filling volume PEEK Implants Titanium Implants PROTI 360°

7 mm 0.4 cc 08.812.007S 04.812.007S 108812007

8 mm 0.4 cc 08.812.008S 04.812.008S 108812008

9 mm 0.5 cc 08.812.009S 04.812.009S 108812009

10 mm 0.6 cc 08.812.010S 04.812.010S 108812010

11 mm 0.7 cc 08.812.011S 04.812.011S 108812011

12 mm 0.8 cc 08.812.012S 04.812.012S 108812012

13 mm 0.9 cc 08.812.013S 04.812.013S 108812013

14 mm 1.0 cc Not Available Not Available 108812014

15 mm 1.0 cc 08.812.015S 04.812.015S 108812015

16 mm 1.2 cc Not Available Not Available Not Available

17 mm 1.3 cc 08.812.017S 04.812.017S Not Available

T-PAL Implant, 5° angle*, large footprint 12 × 32 mm

Heights Filling volume PEEK Implants Titanium Implants PROTI 360°

7 mm 0.6 cc 08.812.207S 04.812.207S 108812207

8 mm 0.7 cc 08.812.208S 04.812.208S 108812208

9 mm 0.8 cc 08.812.209S 04.812.209S 108812209

10 mm 0.9 cc 08.812.210S 04.812.210S 108812210

11 mm 1.1 cc 08.812.211S 04.812.211S 108812211

12 mm 1.2 cc 08.812.212S 04.812.212S 108812212

13 mm 1.4 cc 08.812.213S 04.812.213S 108812213

14 mm 1.6 cc Not Available Not Available 108812214

15 mm 1.7 cc 08.812.215S 04.812.215S 108812215

16 mm 1.9 cc Not Available Not Available Not Available

17 mm 2.0 cc 08.812.217S 04.812.217S Not Available


Height

Height Posterior Height

* 7 mm height = 0°

T-PAL Implant, 5° angle*, small footprint 10 × 28 mm

Heights Posterior height PEEK Implants Titanium Implants PROTI 360°

7 mm 7.0 mm 08.812.007S 04.812.007S 108812007

8 mm 7.2 mm 08.812.008S 04.812.008S 108812008

9 mm 8.2 mm 08.812.009S 04.812.009S 108812009

10 mm 9.2 mm 08.812.010S 04.812.010S 108812010

11 mm 10.2 mm 08.812.011S 04.812.011S 108812011

12 mm 11.2 mm 08.812.012S 04.812.012S 108812012

13 mm 12.2 mm 08.812.013S 04.812.013S 108812013

14 mm 13.2 mm Not Available Not Available 108812014

15 mm 14.2 mm 08.812.015S 04.812.015S 108812015

16 mm 15.2 mm Not Available Not Available Not Available

17 mm 16.2 mm 08.812.017S 04.812.017S Not Available

T-PAL Implant, 5° angle*, large footprint 12 × 32 mm

Heights Posterior height PEEK Implants Titanium Implants PROTI 360°

7 mm 7.0 mm 08.812.207S 04.812.207S 108812207

8 mm 7.0 mm 08.812.208S 04.812.208S 108812208

9 mm 8.0 mm 08.812.209S 04.812.209S 108812209

10 mm 9.0 mm 08.812.210S 04.812.210S 108812210

11 mm 10.0 mm 08.812.211S 04.812.211S 108812211

12 mm 11.0 mm 08.812.212S 04.812.212S 108812212

13 mm 12.0 mm 08.812.213S 04.812.213S 108812213

14 mm 13.0 mm Not Available Not Available 108812214

15 mm 14.0 mm 08.812.215S 04.812.215S 108812215

16 mm 15.0 mm Not Available Not Available Not Available

17 mm 16.0 mm 08.812.217S 04.812.217S Not Available

Implants







Instruments

03.812.307– T-PAL Small Trial Implant size 7–17 mm, 03.812.317 non detachable

03.812.507– T-PAL Large Trial Implant, size 7–17 mm, 03.812.517 non detachable









03.605.529 Curette, rectangular, angled, right, bayoneted, black

03.605.530 Curette, rectangular, angled, left, bayoneted, black






03.605.511 Rasp, dual-sided, angled, bayoneted, black

Instruments


389.857 – Soft Tissue Retractor, width 6, 8, 10 mm 389.859

389.767– Shaver for Intervertebral Discs, 389.777 size 7–17 mm



03.812.007– T-PAL Small Trial Implant, size 7–17 mm 03.812.017

03.812.207– T-PAL Large Trial Implant, size 7–17 mm 03.812.217

Optional Instruments


Sets

Vario Case

68.812.001 Vario Case for T-PAL

Instruments





03.812.307– T-PAL Small Trial Implant, size 7–17 mm,

03.812.317 non detachable

03.812.507– T-PAL Large Trial Implant, size 7–17 mm,

03.812.517 non detachable






Vario Case

68.812.002 Disc Removal Set for T-PAL Instruments




03.605.511 Rasp, dual-sided, angled, bayoneted,

black




03.605.529 Curette, rectangular, angled, right,

bayoneted, black

03.605.530 Curette, rectangular, angled, left,

bayoneted, black


03.605.532 Impactor, curved, standard, bayoneted,

black


389.857– Soft Tissue Retractor,

389.859 width 6, 8 and 10 mm

389.767– Shaver for Intervertebral Discs,

389.777 size 7–17 mm



Attach positionPull the security ring down and simultaneously turn the knob counterclockwise. No gap between the handle, security ring and the applicator knob should be present. The green color band should not be visible.

The implant or trial can be attached.

Insertion positionTurn the applicator knob clockwise to close the jaws. During this closing procedure the security ring moves upwards, so that the green color band is visible. Continue to turn the knob until it is tightened.

In the insertion position; the implant or trial is fixed. The implant or trial cannot pivot or detach.

Applicator Instructions


Pivoting positionTurn the applicator knob counterclockwise until it stops. The applicator knob and the security ring will now be in contact.

In this position the implant or trial can pivot 80°. Implant or trial cannot detach from applicator.

Detach positionPull the security ring down and simultaneously turn the knob counterclockwise. No gap between the handle, security ring and the Applicator knob should be present. The green color band should not be visible.

The implant or trial can be detached.



2

12

12

1

3

Applicator Outer ShaftInner ShaftKnobT-PAL Small Trial Implant, size 7–17 mm, non detachableT-PAL Large Trial Implant, size 7–17 mm, non detachable

03.812.00103.812.00303.812.004

03.812.307–31703.812.507–517

4


Possible damage• Overlaying deformation at the

edge of the groove

Prevention• none

Recommendation• Exchange instrument

Function Control



Filling Material

chronOS is a bone graft substitute consisting of pure β-tricalcium phosphate. Its compressive strength is similar to that of cancellous bone once it has been incorporated and remodeled. Based on literature, the use of β-tricalcium phosphate in the spinal column is a valuable alternative to allografts and autografts, even when larger amounts are required.

Resorbable It is being replaced in the human body by host bone in 6 to 18 months; depending on the indication and the patient’s conditions.

Synthetic Having a synthetic origin, chronOS offers the advantage of uniform quality and unlimited availability.

Osteoconductive Interconnected macropores of defined size (100–500 μm) facilitate bone formation throughout the entire implant. Interconnected micropores (<10 μm) allow supply of nutrients.

Osteoinductive with bone marrow The patient’s blood, blood platelet concentrate or bone marrow aspirate enhances the properties of chronOS required for fusion.

chronOS Granules

Art. no. B (mm) cc

710.000S 0.5–0.7 0.5

710.001S 0.7–1.4 0.5

710.002S 0.7–1.4 1

710.003S 0.7–1.4 2.5

710.011S 1.4–2.8 2.5

710.014S 1.4–2.8 5

710.019S 1.4–2.8 10

710.021S 1.4–2.8 20

710.024S 2.8–5.6 2.5

710.025S 2.8–5.6 5

710.026S 2.8–5.6 10

710.027S 2.8–5.6 20

chronOS – synthetic β-tricalcium phosphate cancellous bone substitute

0086

T-PAL™ ProTi 360º™ SystemManufactured by:Tyber Medical, LLC83 South Commerce Way, Suite 310Bethlehem, PA 18107Phone: +1 (866) 761-0933Fax: +1 (866) 889-9914

Not all products are currently available in all markets.

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.depuysynthes.com/ifu 0123

MDSS GmbHSchiffgraben 4130175 Hanover Germany

T-PAL™ Interbody System PEEK and Ti Manufactured and Distributed by: Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00

www.depuysynthes.com

EC REP

For recognized manufactrer refer to product label

© D

ePuy

Syn

thes

Spi

ne, a

div

isio

n of

Syn

thes

Gm

bH. 2

018.

All

right

s re

serv

ed.

DS

EM

/SP

N/0

714/

0145

098

042-

1808

31

09/1

8

Documents

Surgical Technique - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes... · Designed to guide and turn the cage into the desired position Pyramidal teeth Designed