SPINAL elements


6 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  DIAMOND™ CERVICAL PLATE SYSTEM This package insert covers the Diamond™ Cervical Plate System and Manual Surgical Instruments that are used for the implantation of this system. Specific sections for implants and instrumentation highlight important user information for only those devices. GENERAL INFORMATION The Diamond™ Cervical Plate System is a plate and screw system composed of medical grade titanium per ASTM F136 (Ti6Al-4V ELI) and nitinol (NiTi) components per ASTM F2063. Titanium fixed, and variable angle screws are available in various diameters and lengths. The titanium plate contains integrated locking washers composed of nitinol. These washers secure the bone screws into the plate. The system is intended to provide mechanical support to the implanted level until biologic fusion is achieved. Various instruments are available to facilitate the implantation of the device. The instruments are made from stainless steel per ASTM F899. The handles of certain instruments are made from Radel R-5500 per ASTM D6394 INDICATIONS The Diamond™ Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: • Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) • Trauma (including fractures) • Tumors • Deformities or curvatures (including kyphosis, lordosis, or scoliosis) • Pseudarthrosis • Failed previous fusion • Spondylolisthesis • Spinal Stenosis.  Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. CONTRAINDICATIONS 1. An active infection 2. Suspected or documented allergy to titanium or nitinol materials WARNING THIS DEVICE IS NOT APPROVED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC OR LUMBAR SPINE. Never reuse an implant under any circumstances. Even when a removed device appears undamaged, it may contain small defects or residual stresses. These defects and stresses may lead to implant failure. Any retrieved devices should be handled in a manner such that they may not be reused in another surgical procedure. Note: Titanium and stainless-steel components should not be used together.  Implants and instruments are provided non-sterile. Instruments must be cleaned and sterilized before use. Implants may be processed prior to use and must be sterilized before use. Validated sterilization cycle parameter protocols are noted in the sterilization section of this insert. Implants that have come in direct contact with a patient or bio-contaminants should be disposed of. Some instruments may be sharp, depending on their intended use. Care should be taken in handling such instruments to avoid injury to the user or patient. A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many extenuating circumstances may compromise the results. System components are temporary implants used for the correction and stabilization of the spine. Devices are intended to be used to augment the development of a spinal fusion by providing temporary stabilization. Devices are not intended to be the sole means of spinal support. Use of these products without a bone graft or in cases that develop into a non-union will not be successful. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s) will occur. Implantation of devices should be performed only by experienced spinal surgeons with specific training in the use of this LB-006  Page 1 of 6  Rev. 20210611
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