SPINAL elements

SAMSOM CORPECTOMY System Instructions for Use

5 Pages

SAMSON CORPECTOMY® SYSTEM This package insert covers the Samson Corpectomy® System and Manual Surgical Instruments that are used for the implantation of this system. Specific sections for implants and instrumentation highlight important user information for only those devices. DESCRIPTION The Samson Corpectomy® is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The implants have ridges or teeth in both the superior and inferior directions, which resist migration. The implants have cavities to accept packing of autograft and/or allograft. The entire structure is radiolucent so that healing can be assessed by normal radiographic methods. Additionally, radiotherapy can be performed immediately after surgery. The materials used in the implant are listed on the packages. Implants are made from PEEK or Titanium Alloy per ASTM F2026. To ensure radiographic visibility for inspecting the implant position, they contain marker pins made of x-ray opaque implant material (Tantalum) per ASTM F560. INDICATIONS The Samson Corpectomy® is a vertebral body replacement system indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Samson Corpectomy® is intended for use with supplemental fixation and is to be used with autograft and/or allograft. CONTRAINDICATIONS 1. Fractures 2. Scoliosis 3. Active infection 4. Allergy to tantalum, PEEK or Titanium Alloy (Ti-6Al-4V ELI) 5. Bone tumors in the region where the implant would have to be anchored 6. Unwillingness or inability of the patient to follow the instructions for postoperative treatment 7. Any medical or surgical condition that could preclude the potential success of the implantation 8. Pregnancy 9. Osteoporosis or similar loss of bone density 10. Systemic or metabolic diseases 11. Drug abuse or alcoholism 12. Generally poor condition of the patient 13. Morbid obesity 14. Psychosocial issues; inadequate co-operation by the patient 15. Fever or leukocytosis 16. Any case not needing a fusion 17. Patients with a know hereditary or acquired bone friability or calcification problem should not be considered for this type of surgery 18. These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth 19. Any case where the implant components selected for use would be too large or too small to achieve a successful result 20. Any case that requires the mixing of metals from two different components or systems 21. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality 22. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance 23. Prior fusion at the level to be treated 24. All cases that are not listed under indications WARNINGS 1. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory anterior column support is increased by the selection of the proper size device. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing. 2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation appliances are load-sharing devices that are used to obtain an alignment until normal healing occurs. If healing is delayed, or does not occur, the implant may eventually break due to material fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure.  LB-065 Rev 20190716
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File Name: SPINAL elements - LB-065 - SAMSOM CORPECTOMY System Instructions for Use - 2019-07.pdf

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