France Hôtel de Bureaux 1, 4 rue Gustave Eiffel, 10430 Rosières Près Troyes Adresse postale : Technopôle de l’Aube BP 2 10902 Troyes Cedex 9, France +33 (0)3 25 82 32 63 China Beijing Global Trade Center #36 North Third Ring Road East, Unit 06, Level 19, Building A, Dongcheng District, Beijing, China, 100013 +86 10 58256655 Brazil Av. Pereira Barreto, 1395 Torre sul - CJ 193 - Bairro Paraiso Santo André - São Paulo CEP : 09190-610 Brazil +55 11 43327755 United States 13785 Research Boulevard Suite 200 Austin, TX 78750 USA 512.344.3333 LDR, LDR Spine, LDR Médical, BF+, BF+(ph), Easyspine, C-Plate, SpineTune, MC+, Mobi, Mobi-C, Mobi-L, Mobidisc, ROI, ROI-A, ROI-T, ROI-C, Avenue L and verteBRIDGE are trademarks or registered trademarks of LDR Holding Corporation or its affiliates in France, the United States or other countries. CERVICAL DISC PROSTHESIS SURGICAL TECHNIQUE Document intended for the exclusive use of healthcare professionals. MOBI-C®- Sterile cervical disc prosthesis- is a class IIb CE marked medical device made by the LDR Medical S.A.S. Company and for which the conformity assessment was carried out by the notified body G-Med N°0459. MOBI-C® prosthesis is a device for cervical intervertebral disc replacement (C3/C4, C4/C5, C5/C6, C6/C7) in order to restore segmental motion and disc height. Before any surgical procedure, read carefully the instructions and the surgical technique.

SURGICAL TECHNIQUE Pre-operative considerations Implant height determination must be carried out in such a way as to not exceed the height of healthy adjacent discs. A minimal antero-posterior depth of 14mm at the affected level must be verified by x-ray. This measurement will then be verified intra-operatively by direct measurement with the depth gauge. All measurements must take into consideration any osteophytes that will be resected at the beginning of the procedure. The surgical approach is identical with that of a classic anterior cervical arthrodesis. IMPORTANT: Intraoperative x-rays will...

Partial discectomy Proceed with a classic discectomy. Start with the anterior portion of the disc (annular tissue) releasing as much of the uncus as possible. Take care to remove all anterior osteophytes. Midline and width determination Insert the width gauge into the disc space. Position the width gauge flat on the inferior endplate, in contact with the base of the uncus. Once the proper width is selected and the width gauge is centered on the vertebra a reference mark can be made on the superior vertebra to identify the midline. Note: The center reference point, located on the width gauge,...

SURGICAL TECHNIQUE Caspar distractor placement The second Caspar pin is in turn inserted in the inferior vertebral body about 5mm from the superior endplate. Using the distraction forceps, proceed with an initial distraction of the disc space. The pins must be parallel to themselves and parallel with the vertebral endplates in order to ensure parallel distraction. The Caspar distractor is then attached and tightened to maintain the desired distraction. Note: In the case of a 2-level procedure, the Caspar pin may be placed at mid-height in the vertebral body. Remove the distraction forceps.

Complete discectomy Parallel distraction Insert the distraction forceps as posterior as possible. A progressive and parallel distraction must be obtained. It is advised to alternately lateralize the distraction forceps in order to optimize the distraction. A complete discectomy of the disc space between the uncus and up to the posterior ligament is performed. It is important to remove all posterior osteophytes on the superior and inferior endplates. Once the desired distraction is obtained, lock the Caspar distractor in order to maintain the distraction. Note: To prevent weakening the vertebral...

SURGICAL TECHNIQUE Trial implants The depth and width measurements previously taken help determine the trial sizes to use. The trials will determine the final implant height to be used as well as implant size (width and depth). Each size is color coded. Available heights are 4.5, 5, 6, and 7mm*. Trialing should begin with a height that does not exceed the height of healthy adjacent discs. The trial is screwed onto the trial implant holder and, under fluoroscopy, inserted into the disc space. Important: It is imperative to cover a maximum of the vertebral endplates without exceeding their depth....

Loading the prosthesis Handling of the prosthesis is accomplished with the help of the Mobi-C implant holder. Before handling, check that the stop adjustment dial is set to the zero (0) position (Figure 1). The "prosthesis + clamps" assembly is loaded onto the implant holder by turning the impaction knob until the assembly is completely screwed and in contact with the holder (Figure 2). Millimetric adjustment of the stop The implant holder has a stop (set beforehand on zero (0)). This stop allows for setting the insertion depth of the prosthesis from 0 to 5mm. Impaction Knob Notes: Visual control...

SURGICAL TECHNIQUE Prosthesis insertion The implant holder must be positioned in the axis of the disc, the Caspar distractor maintaining the intervertebral distraction. The position can be verified visually: the groove on the implant holder should align with the Caspar pin. The prosthesis is inserted progressively, under fluoroscopy, into the disc space by tapping gently on the implant holder's impaction knob with a mallet. In order to check the correct position in rotation of the implant holder, use the level rod as shown in the illustration below. Note: Take care to center the prosthesis on...

Position checking – lateral view Millimetric readjustment of prosthesis position under fluoroscopy. Fluoroscopic control facilitates assessment of correct prosthesis position. Release the Caspar in order to put the vertebral endplates in parallel. The antero-posterior position of the prosthesis in the intervertebral space can be adjusted, if necessary, with millimetric adjustment of the implant holder's stop. Note: From the lateral view, visual assessment of the alignment of the tabs on the inferior plate is used to control the position of the prosthesis in rotation. Reminder: The prosthesis...