FREEDOM Nail Instructions for Use

12 Pages

NuVasive Specialized Orthopedics, Inc. FREEDOM Nail Instructions for Use Product Description: The FREEDOM Nail is composed of an implantable intramedullary nail, locking screws, reusable instruments, and a hand-held External Remote Controller (ERC). The FREEDOM nail is a sterile single use device that is surgically implanted using the instruments and locking screws. The FREEDOM System implants are manufactured from Titanium 6AL-4V per ASTM F136. The ERC is used daily after implantation to non-invasively lengthen or shorten the implant to a prescribed length. Following implantation, the FREEDOM System utilizes distraction osteogenesis to lengthen the residual limb. Traditional intramedullary surgical techniques are used to implant and secure the proximal and distal sections of the FREEDOM nail to the target bone. The FREEDOM nail includes a small internal magnet and gearing. After positioning the External Remote Controller (ERC) against the skin over the internal magnet, activation of the ERC causes the magnet to rotate and either lengthen or shorten the FREEDOM nail. Over a period of days, weeks, or months, sequential distractions are used to produce the target residual limb length. The FREEDOM nail remains implanted until bone consolidation has been completed. Once the physician determines that the nail has achieved its intended use and is no longer required, it is removed using standard surgical techniques. Indication for Use: The FREEDOM nail is indicated for lengthening of the residual limb of the femur in adults. Contraindications: • Infection or Pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the device. • Metal allergies and sensitivities. • Patients whose distance from the surface of the treated limb to the intramedullary canal is greater than 51 mm. • Patients in which there is an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations, peripheral vascular disease or evidence of inadequate vascularity. • Patients in which the FREEDOM Nail would cross joint spaces or open epiphyseal growth plates. • Patients unwilling or incapable of following postoperative care instructions. Potential Adverse Events and Complications: As this is a major surgical procedure, there are known complications associated with orthopedic surgery such as bone fractures, nonunion, delayed union, malunion, premature healing (consolidation), decrease in bone density due to stress shielding, inadequate screw fixation, difficulty with nail or screw removal, early or late infection that may result in the need for additional surgeries, damage to blood vessels or nerves, deep venous thrombosis or pulmonary emboli, acute local inflammatory response, loss of sensory and/or motor function or paralysis, pain, and/or permanent deformity. The following list of failures and adverse events are possible with the Precice IMLL system. Failure to follow the contraindications, warnings, cautions and precautions listed in this IFU constitute off-label use and may increase the likelihood of these events.  LC0097 Rev M-2/2022  P a g e |1
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File Name: NuVasive - LC0097 - FREEDOM Nail Instructions for Use - 2022-02 - Rev M.pdf

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