Blackbird Spinal System Instruction for Use

4 Pages

• • • •  Cautions, Precautions, Warnings, Possible Adverse Effects  Blackbird™ Spinal System Instruction for Use  Cautions: •  Implants  • Choice Spine 400 Erin Drive Knoxville, TN 37919  Important Note to Operating Surgeon: The Choice Spine BLACKBIRD™ Spinal System is designed to provide biomechanical stabilization as an adjunct to fusion. Spinal fixation should only be undertaken after the surgeon has had hands on training in this method of spinal fixation and has become thoroughly knowledgeable about spinal anatomy and biomechanics. A spinal technique is available for instructions on the important aspects of this surgical procedure. General Description: The Choice Spine BLACKBIRD™ Spinal System is a comprehensive system for posterior fixation of the cervical and upper thoracic spine. It is to be implanted posteriorly. The system is composed of polyaxial screws and smooth shaft polyaxial screws in various sizes, set screws, straight rods, pre-bent rods, transition rods, cross connectors, lateral offset connectors, rod transition connectors, and hooks. All implant components will be made from Ti 6Al 4V-ELI alloy or Cobalt-28 Chromium-6 Molybdenum Alloy per ASTM F1537. Associated instrumentation will accompany the implant components. Instruments will be made from biocompatible materials. Indications for Use: The Choice Spine BLACKBIRD™ Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion for stabilization of the cervical spine & thoracic spine (C1-T3) for the following conditions: • degenerative disc disease (DDD; defined as neck pain of discogenic origin with degeneration of the disk as confirmed by history & radiographic studies) • spondylolisthesis • trauma • fracture / dislocation • spinal stenosis • atlanto/axial fracture with instability • tumor • revision of previous cervical spine surgery The use of polyaxial screws is limited to the thoracic spine (T1-T3) “ for anchoring the construct only” and not intended to be placed in the cervical spine. The use of the rods and hooks are intended to provide stabilization and promote fusion in the cervical / upper thoracic (C1-T3) spine. This system can be linked to a Ø6.0 mm rod system such as the Choice Spine Starfire™ Pedicle Screw System. Contraindications: Contraindications include, but are not limited to: • • • • • • • • •  presence of congenital abnormalities, vague spinal anatomy, tumors, or any other condition which prevents secure implant screw fixation and/or decreases the useful life of the device any condition having inadequate tissue coverage over the operative site any circumstances not described under Indications for Use patients unwilling or unable to follow post-operative instructions  infection, systemic or localized signs of local inflammation morbid obesity fever or leukocytosis mental illness alcoholism or drug abuse pregnancy severe osteopenia suspected or documented sensitivity or allergies to the implant materials  •  Mixing of dissimilar metals can accelerate the corrosion Process. Stainless steel and titanium components must NOT be used together. Do not use components of the Blackbird™ Spinal System with components from any other manufacturer. As with all orthopedic implants, none of the Blackbird™ Spinal System components should ever be reused under any circumstances.  Precautions: • The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. • 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 the consequences. Other poor candidates for spine fusion include obese malnourished, those with poor muscle and bone quality, and nerve paralysis patients. Warnings: The safety and effectiveness of pedicle screw spinal 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 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. This device system is not intended to be the sole means of spinal support. It’s use without a bone graft or in cases that develop into a non-union will not be successful. No spinal implant can withstand the loads of the body without maturation of a solid fusion mass, and in this case, bending, loosening or fracture of the implant will eventually occur. The proper selection and compliance of the patient will greatly affect the results. The implantation of Choice Spine BLACKBIRD™ spinal systems should be performed only by spinal surgeons fully experienced in the surgical techniques required for the use of such implants. Even with the use of spinal implants, a successful result in terms of pain,function, or fusion is not always achieved in every surgical case. The Choice Spine BLACKBIRD™ Spinal System has not been evaluated for safety and compatibility in the MR environment. This system has not been tested for heating or migration in the MR environment. Preoperative: Preoperative instructions to the patient are essential. The patient should be made aware of the limitations of the implant and potential adverse effects of the surgery. Only patients who meet the criteria described in the Indications section should be selected for implantation. Patient conditions and/or predispositions such as those addressed in the Contraindications section should be avoided. Care should be used in the handling and storage of the implant components. The implants should not be damaged. Implants should be protected from corrosive elements during storage. The type of construct required for the surgery should be determined prior to beginning the surgery. Implants and instruments must be inspected, cleaned and sterilized prior to use in the operative field. Intraoperative: Caution should be used around the spinal cord and nerve roots, particularly when using screws. Damage to the nerves may cause loss of neurological functions. Breakage, slippage, misuse, or mishandling of the instruments or implant components, such as on sharp edges, may cause injury to the patient or operative personnel. The implants must be handled and contoured carefully so as to avoid CS.Blackbird.IFU Rev03 11/17
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