CD Horizon Fenestrated Screws
CD Horizon™ Solera™ 5.5/6.0 mm Fenestrated Screws offer the same design and capabilities of the CD Horizon Solera Spinal System Screws, with the addition of six fenestrations near the tip. These features allow Medtronic HV-R™ Fenestrated Screw Cement to pass directly through the screw shaft and fenestrations, providing immediate enhanced fixation in patients with poor bone quality due to advanced stage tumors.
CD Horizon Solera 5.5/6.0 mm Fenestrated Screws bring control and confidence for complete tumor management when fixation is necessary in advanced stage tumor patients.
Instructions for Use Manual
Find this technical manual in the product labeling supplied with each device or call Medtronic at 800-961-9055.
When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement, the CD HORIZON™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON™ Fenestrated Screws augmented with Medtronic HV-R™ Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
When used without cement, the CD HORIZON™ Fenestrated Screws (with or without SEXTANT™ or LONGITUDE™ instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion.
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other patient conditions may compromise the results. The use of bone cement presents some risk including extravasation of bone cement potentially resulting in but not limited to compression or irritation of nerve structures such as the spinal cord or nerve roots causing radiculopathy, paresthesia, paraplegia, paralysis, and/or; introduction into the vascular system resulting in embolism of the lung and/or heart or other clinical sequelae. It can also lead to serious adverse events, some with fatal outcome including cardiac arrest, cerebrovascular accident, myocardial infarction, and pulmonary embolism. Clinical hardware risks include loosening of implants, fracture of implants and/or fracture, microfracture, resorption, damage or penetrated of the spinal bone.
Reference the appropriate surgical technique and package insert for guidance, indications, contraindications, and warnings for these cleared Medtronic systems.