SPINAL elements

MOSAIC CERVICAL INTERBODY System Instructions for Use

5 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  CERVICAL SPINE IMPLANTS AND INSTRUMENTATION MOSAIC CERVICAL INTERBODY SYSTEM AND INSTRUMENTATION GENERAL INFORMATION Spinal Elements’ Mosaic Cervical Interbody System is composed of a device body and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry and teeth on its external surfaces. The boxshaped body has projections (or flanges) that encompass screw holes. Screws pass through screw holes and affix to bone to help prevent implant migration. Devices are available in a multitude of sizes. Device bodies are made from either titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3 or polyetheretherketone PEEK-Optima®) conforming to ASTM F 2026. Screws are made from Ti-6Al-4V per ASTM F 136 or ISO 5832-3. All implants are intended for single use only and should not be reused under any circumstances. Reuse may result in serious injury or death. Components from this system should not be used in conjunction with components from other systems. INDICATIONS The Mosaic device is an interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two, three, or four screws. The maximum number of screws should be used to ensure adequate fixation of the implant. CLEANING AND MAINTENANCE 1. Inserters and Spring-Loaded Awls should be disassembled before cleaning by compressing the button and removing the external shaft from the handle. 2. Follow the cleaning instructions listed in the Manual Surgical Instruments section of this insert. Pay special attention to the lumens of the external shafts of disassembled instruments and all guide sleeves. 3. An instrument lubricant should be applied to the ratchet teeth on the internal shaft of inserters and to the ratcheting mechanism of the Mosaic Gun after cleaning. 4. An instrument lubricant should be applied to all hinged instruments after cleaning. INTRAOPERATIVE MANAGEMENT 1. Flanged trials should be used prior to placement of the device body to ensure proper fit. 2. The device body should be attached to the corresponding inserter such that it is fully seated on the inserter. 3. The device body should not be axially rotated with the inserter once it has been implanted. This may lead to damage of the implant and/or the inserter. 4. If the surgeon experiences difficulty in inserting screws (i.e. hard bone, etc), drilling and/or tapping prior to screw insertion is recommended. 5. A drill guide should be used to limit the angle of drilling and subsequent insertion of screws. Insertion angles greater than what the drill guides allow may prevent adequate locking of the screw. 6. To help prevent screws from disassociating from the plate postoperatively, the screw locking mechanism of each screw should be engaged. The screw locking mechanism is activated by the clockwise rotation of the inset screw within the bone screw by the Breakaway Driver until an audible “click” is heard, indicating that the locking mechanism has been activated. To ensure that the locking mechanism has been activated, it is recommended to continue rotating the inset screw until a second audible “click” is heard. 7. Before the closing of the soft tissues, all screws should be secured to the device body by activating the locking mechanism as described.  INS-CERCE  Page 1 of 5  Rev. 20200224
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File Name: SPINAL elements - INS-CERCE - MOSAIC CERVICAL INTERBODY System Instructions for Use - 2020-02.pdf

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