SPINAL elements

TALON SPINE SYSTEM Implants and Instrumentation Instructions

7 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  TALON SPINE SYSTEM IMPLANTS AND INSTRUMENTATION This package insert covers the Talon Spinal System and Manual Surgical Instruments that are used for the implantation of this system. GENERAL INFORMATION The Talon Spinal System consists of longitudinal rods, monoaxial screws, polyaxial screws, and transverse connectors. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136. System components are available in a multitude of sizes and configurations. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. INDICATIONS The Talon Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis). CONTRAINDICATIONS Disease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices. Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation. Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system. Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure. See also the warnings, precautions and possible adverse effects concerning temporary metallic internal fixation devices section of this insert. WARNINGS/PRECAUTIONS Implants and instruments are provided non-sterile. Instruments must be cleaned and sterilized before use. Implants may be reprocessed 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 biocontaminants 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. The safety and effectiveness of pedicle screw systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grade 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. 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  OMNI-LB-141  Page 1 of 7  Rev. 20210520
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File Name: SPINAL elements - OMNI-LB-141 - TALON SPINE SYSTEM Implants and Instrumentation Instructions - 2021-05 - 20210520.pdf

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