SURGICAL TECHNIQUE ROI C ROI C ROI C Lordotic - LDRfr.ldr.com/Portals/11/PDF/Products/ROI-C/Surgical... · 2016-02-03 · SURGICAL TECHNIQUE Insertion of the first half anchoring

ANTERIOR CERVICAL CAGE

USE OF THE STERILE STARTER AWL FOR ROI‐C ANCHORING PLATE AND ANCHORINGPLATE POSITIONING.

Cancel and replace the step "Anchoring plate positioning" of the ROI‐C surgical technique (IR‐C ST 1 EN),ROI‐C Bi‐Pack (IR‐C/BP ST 1 EN) and ROI‐C Lordotic (IR‐C ST 3 EN).

A D D E N D U MS U R G I C A L T E C H N I Q U E

ROI-C®, ROI-C®

BI-PACK®

and ROI-C® Lordotic

TECHOP_ROI-C_EN _Addendum_Mise en page 1 20/01/2016 10:24 Page 1


S U R G I C A L T E C H N I Q U E

Pathway preparation and setting up of the anchoring plate

Pathway preparation of the first half anchoring plate

In normal bone structure, the insertion of the half anchoring plate is a simple and effortless step . Nevertheless, in order to prepare the half anchoringplate pathway in vertebrae, the sterile starter awl use is recommended for ROI-C surgery. Its use is left to the surgeon’s own estimation, according to hisexperience of surgery , of the product, of the patient pre-operative assessment, and per-operative signs on the bone density of the instrumented level(s).

Choice of the ROI-C sterile starter awls for ROI-C anchoring plate:

n Select the sterile starter awl (Short « S » or Long « L ») according to the half anchoring platelength to be inserted.

- Use a sterile short starter awl (« S ») for the use of a short half anchoring plate.

- Use a sterile long starter awl (« L ») for the use of a long half anchoring plate.

Note: The sterile starter awls are delivered per unit in sterile box.

When the cage position is optimal and the segment is put into compression, the anchoring plate (composed of two half anchoring plates) can beinserted. Impaction of the half anchoring plates is done one after another (in the inferior vertebra, then in the superior one) following preparation oftheir pathway with the sterile starter awl for ROI-C anchoring plate.

Important: If the pins have not been properly placed during the discectomy, they canimpede anchoring plate preparation and insertion. In this case, remove the distractorand the Caspar pins.

1Step

1aStep


Assembly of the sterile starter awl onto the starter awl impactor for ROI-Canchoring plate

Take the sterile starter awl previously selected and assembly it onto the starterawl impactor through the next steps:

n Take the sterile starter awl out of its packaging by taking it by the siliconeprotective cap.

n Insert the sterile starter awl as describe below, by respecting imperativelythe marking direction.

- Adjust the « S » or « L » marking face to the starter awl impactor,and insert the open part of the sterile starter awl on the starterawl impactor, by letting it slide against the blue pawn.

- Remove and discard the silicone protective cap.

- Slide the guide to the sterile starter awl until contact with thisone against the groove back.

Guide Groove back

Starter awl impactor for ROI-C anchoring plate

WRONG INSERTION

3‐4

GOOD INSERTION



Important: Verify the sterile starter awl's integrity (the cutting of the sterile starter awl) before impaction.

During its use, the sterile starter awl comes in contact with the ROI-C instrumentation and the patient’s cortical bone, it isnormal to observe superficial marks without its integrity is questioned. Non acceptable damage to the starter awl can beobserved for instance in case of contact with an obstacle on its trajectory (pins, …).

Important: For each instrumented level, it is essential to follow the next steps:- Pathway preparation in the first vertebra- Insertion of the half anchoring plate into the same vertebra- Pathway preparation into the second vertebra- Insertion of the second half anchoring plate into the second vertebra

The pathway in the second vertebra must not be prepared at the same time that the one of the first vertebra.

Use of the sterile starter awl for the pathway creation

Non acceptableAcceptable Non acceptableAcceptable

Discard the damagedstarter awl and take anew sterile one.


n Insert the starter awl impactor rod into the implant holder’s groove (Fig.01).

n In order to prepare the pathway of the half anchoring plate destined to theinferior vertebra, adjust the laser marking « 1 » located on the guide side, soit is the opposite of the implant holder’s body (Fig.02).

n Insert the sterile starter awl into the superior slot of the implant holder head.No resistance must be felt during the sterile starter awl insertion into the slot.If resistance is felt, remove the sterile starter awl and repeat the step (Fig.03).

n Bring the sterile starter awl in contact to the vertebral endplate bone (lightresistance) by manually thimbing the starter awl impaction knob (Fig.03).

n Start the insertion with a series of 3 to 4 impactions on the impaction knobwith a mallet. The sterile starter awl is then partially inserted into thevertebral body (Fig.04).

n Extract the sterile starter awl completely by reverse impaction under theimpaction knob (Fig.05).

n Start again these steps until the starter awl impactor body reaches itsmechanical stop with the guide (Fig.06).

n Perform a X-ray control to validate the good insertion of the sterile starter awl(Fig.07).

n Proceed to the sterile starter awl removal by using a mallet.

Important: In case where a strong resistance is felt, immediatly stop theinsertion and perform X-ray to determinate the reason of the resistance(contact with Caspar pins,….). Remove if necessary the material at theorigin of the conflict in order to avoid any interferences.

Important: The impaction of the sterile starter awl must be done progressivelyby respecting the complete withdrawal steps, as described below:

Starter awlimpactor body

Starter awlimpactor rod

Implant holdergroove

Impactionknob

Mechanicalstop

5‐6

Fig.01

Fig.02

Fig.03 Fig.04

Fig.05 Fig.06

Fig.07



Insertion of the first half anchoring plate

n The first half anchoring plate is inserted in the superior slot ofthe cage holder with the ROI-C anchoring plate holder (inthe axis of the cage holder with a minimum of obstruction).

n Impact the half anchoring plate using the ROI-C impactor(marked 1) until it reaches its mechanical stop.

Important: During half anchoring plate insertion, makesure to push the plate all the way to the bottom of theimplant holder head with the ROI-C anchoring plateholder.

1st stage: Roi-C impactor (marked 1)

ROI-C Anchoringplate holder

1bStep

Mechanicalstop


n Complete the impaction using the ROI-C final impactor (marked 2).

Remark: Make sure the impactions are done in the axis of theintervertebral space.

Note: Use fluoroscopy during each step in order toverify correct positioning of the half anchoring plate.

2nd stage: ROI-C final impactor (marked 2)

Mechanical stop

7‐8



Pathway preparation of the second half anchoring plate

n In order to prepare the pathway of the half anchoring plate destinedto the superior vertebra, adjust the laser marking « 2 » located on theguide side, in the way that it is orientated to the opposite of theimplant holder’s body.

n Insert the sterile starter awl into the inferior slot of the implantholder head.

n For the next steps, consult the Step 1a, Chapiter « Pathwaypreparation of the first half anchoring plate », on page 3.

n Discard the sterile starter awl at the end of the surgery.

1cStep

Important: Before every reuse, slide the guide in order to check:

- The sterile starter awl’s integrity for anchoring plate (see Step 1a,Chapiter « Pathway preparation of the first half anchoring plate »).

- The sterile starter awl’s mobility in the starter awl impactor head.

Mechanicalstop


1dStep Insertion of the second half anchoring plate

n Once the second pathway created with the sterile starterawl, insert the second half anchoring plate and impact it byfollowing the same technique that the one used for the firsthalf anchoring plate, while ensuring to insert this secondhalf anchoring plate into the slot at the opposite of the oneused for the first half anchoring plate.

Note: Use fluoroscopy during each step in order toverify correct positioning of the half anchoring plate.

Reminder: The half anchoring plate inserted in theimplant holder’s inferior slot penetrates into thesuperior vertebral body and inversely.

1st stage: Roi-C impactor (marked 1)

2nd stage: ROI-C final impactor (marked 2)

Following this surgical technique of the sterile starter awls for ROI-C anchoring plate , please follow on the ROI-C surgical technique (IR-C ST 1 EN)or ROI-C Bi-Pack (IR-C/BP ST 1 EN) or ROI-C Lordotic (IR-C ST 3 EN) depending to the used implant, to the step "Implant holder removal and finalcontrol".

9‐10



Ref:

IR-C

ST

4 EN

10.

2015

A

FranceHôtel de Bureaux 1,4 rue Gustave Eiffel,10430 Rosières Près TroyesMailing Address:Technopôle de l’Aube BP 210902 Troyes Cedex 9, France+33 (0)3 25 82 32 63

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www.ldr.com

LDR, LDR Spine, LDR Médical, BF+, BF+(ph), Easyspine, C-Plate, SpineTune, MC+, Mobi, Mobi-C, Mobidisc, ROI, ROI-A, ROI-T, ROI-C, Avenue Land VerteBRIDGE are trademarks or registered trademarks of LDR Holding Corporation or its affiliates in France, the United States or other countries.

Document intended for the exclusive use of healthcare professionals. Before any surgical procedure, read carefully the instructions and the surgical technique.ROI-C® - Sterile anterior cervical cage - is a class IIb CE marked medical device made by the LDR Médical S.A.S. Company and for which the conformity assessment was carried out by the notified bodyG-Med N°0459. ROI-C® is intended for fixation of the cervical vertebrae by anterior approach.ROI-C® Bi-Pack® - Sterile anterior cervical cage pre-filled with bone substitute - is a class III CE marked medical device made by the LDR Médical S.A.S. Company and for which the conformity assessmentwas carried out by the notified body G-Med N°0459. ROI-C® Bi-Pack® is intended for fixation of the cervical vertebrae by anterior approach for the levels C2-C3 to C7-T1.


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SURGICAL TECHNIQUE ROI C ROI C ROI C Lordotic - LDRfr.ldr.com/Portals/11/PDF/Products/ROI-C/Surgical... · 2016-02-03 · SURGICAL TECHNIQUE Insertion of the first half anchoring