SPINAL elements


5 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  PHENIX™ CERVICAL INTERBODY SYSTEM IMPLANTS AND INSTRUMENTS This package insert covers the Phenix™ Cervical Interbody System and Manual Surgical Instruments that are used for the  implantation of this system. GENERAL INFORMATION The Phenix™ Cervical Interbody is a cervical interbody fusion device that is implanted from the anterior approach. The device is designed to fit within the outer cortex of cervical spine vertebrae. It is to be packed with autogenous bone graft to facilitate fusion. It is intended to provide mechanical support to the implanted level until biologic fusion is achieved. INDICATIONS The Phenix™ Cervical Interbody is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Phenix™ Cervical Interbody implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation. CONTRAINDICATIONS • An active infection • Suspected or documented allergy to polyetheretherketone or tantalum • Severe osteoporosis • Severe instability at the implanted level WARNINGS Implants provided sterile are sterilized through gamma irradiation. Do not re-sterilize implants provided sterile. Devices provided non-sterile must be cleaned and 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 surgeons with training in the use of spinal devices. This is a technically demanding procedure presenting a risk of serious injury to the patient. Preoperative and operating procedures including knowledge of surgical techniques, proper reduction, and proper selection and placement of the implant are important considerations in the successful utilization of this device by the surgeon. Further, the proper selection and compliance of the patient will greatly affect the results. The physician should consider the levels of implantation, patient weight, patient activity level, and all other patient conditions that may have an impact on the performance of this device. Patients who smoke have been shown to have an increased incidence of non-union. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also poor candidates for spine fusion.  LB-018  Page 1 of 5  Rev. 20201201
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