SPINAL elements


6 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  MAGNUM+ ANTERIOR LUMBAR INTERBODY SYSTEM AND INSTRUMENTATION This package insert covers the Magnum+ Anterior Lumbar Interbody System and Manual Instruments that are used for the implantation of this system. Specific sections for implants and instrumentation highlight important user information. GENERAL INFORMATION Spinal Elements’ Magnum+ device is composed of a main device body and fixation screws. The main device body is generally oval-shaped device with various graft windows throughout its geometry. The main device body also bears screw holes on its anterior surface that allow for the passage of bone screws that affix to bone and help prevent migration. The main device body is made from either titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3, polyetheretherketone (PEEKOptima®) conforming to ASTM F 2026, or PEEK with a coating of commercially pure titanium conforming to ASTM F 1580. Screws are made from titanium alloy (Ti-6AL-4V), conforming to ASTM F 136 or ISO 5832-3. All implants are intended for single patient use only and should not be reused (used in additional patients) under any circumstances. Reuse may result in serious injury or death. Components from this system should not be used in conjunction with components from other systems. INDICATIONS Magnum+ is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels (L2S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Magnum+ is a standalone device intended to be used with bone screws. If the physician chooses to use fewer than the maximum number of screws accommodated by the device, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. CONTRAINDICATIONS 1. Patients with known or probable intolerance to the materials used in the manufacture of this device. 2. Patients with infection, inflammation, fever, tumors, elevated white blood count, obesity, pregnancy, mental illness and other medical conditions which would prohibit beneficial surgical outcome. 3. Patients resistant to following post-operative restrictions on movement especially in athletic and occupational activities. 4. Use with components from other systems. 5. Grossly distorted anatomy caused by congenital abnormalities. 6. Any patient that has had prior fusion surgery at the levels to be treated. 7. Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery. 8. Rapid joint disease, bone absorption, osteopenia. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation. 9. Any case where the implant components selected for use would be too large or too small to achieve a successful result. 10. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. 11. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. 12. Any case not described in the indications for use. 13. Reuse or multiple use. WARNINGS Implants and instruments are provided non-sterile. Instruments must be cleaned and sterilized before use. Implants may be reprocessed prior to use and must be sterilized before use. Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert. Implants that have come in direct contact with a patient or bio-contaminants should be disposed of. Some instruments may be sharp, depending on their intended use. Care should be taken in handling such instruments to avoid injury to the user or patient. INS-MAG+  Page 1 of 6  Rev. 20190823
File Type: PDF
File Size: 279 KB
File Name: SPINAL elements - INS-MAG - MAGNUM+ANTERIOR LUMBAR INTERBODY System Instructions for Use - 2019-08.pdf

By clicking Download you are confirming this is the correct document for your purposes
and that you agree to our Terms & Conditions