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 or Kyphon™ Xpede™ Bone 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 via http://manuals.medtronic.com/manuals/main/region or call Medtronic at 800-933-2635.
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.
When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone 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 either Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
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.
Clinical hardware risks include loosening of implants, fracture of implants and/or fracture, microfracture, resorption, damage or penetrated of the spinal bone.
Cement leakage may cause tissue damage, nerve or circulatory problems, and other serious adverse events. These risks may increase with the number of spinal levels where bone cement is utilized, and also with the volume of bone cement used.
Serious adverse events, some with fatal outcome, associated with the use of acrylic bone cements in the spine include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism, and cardiac embolism. Although the majority of these adverse events present early within the post-operative period, there have been some reports of diagnoses beyond a year or more after the procedure. Other reported adverse events for acrylic bone cements intended for use in the spine include: leakage of the bone cement beyond the site of its intended application with introduction into the vascular system resulting in embolism of the lung and/or heart or other clinical sequelae.
Reference the appropriate surgical technique and package insert for guidance, indications, contraindications, and warnings for these cleared Medtronic systems.