Interbody Systems: Post Market Clinical Follow-up Study

Exclusion Criteria

• •1. Any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery.
• •2. For the Tritanium and Monterey AL systems: Any neuromuscular deficit which places an unsafe load on the device during the healing period.
• •3. For the Cascadia, Chesapeake, Mojave and Sahara systems: Metabolic disorders of calcified tissues.
• •4. Biological factors such as smoking or using nonsteroidal anti inflammatory agents/ anticoagulants.
• •5. Immunosuppressive disorders.
• •6. Grossly distorted anatomy. N/A for Tritanium TL, Tritanium Cervical and Monterey AL
• •7. Inadequate tissue coverage or open wounds.
• •8. Infection at index level(s) at the time of surgery.
• •9. Patients with known sensitivity to materials in the device.
• •10. Has a neuromuscular disorder or mental condition (including general neurological conditions, mental illness, senility, and drug/alcohol abuse) which would create an unacceptable risk of fixation failure or complications in postoperative care or willingness to restrict activities or follow medical advice.
• •11. Obesity.
• •12. Other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC) or marked left shift in the WBC differential count.
• •13. For the Tritanium and Monterey AL systems: Any abnormality which affects the normal process of bone remodeling including, but not limited to severe osteoporosis involving the spine, bone absorption, osteopenia, primary or metastatic tumors involving the spine or certain metabolic disorders affecting osteogenesis.
• •Please note for Tritanium cervical this also includes rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis.
• •14. For the Tritanium, Monterey AL, Chesapeake and Sahara systems: Prior fusion at the level to be treated (as indicated in the IFU).
• •15. Pregnancy, or if the patient intends to become pregnant during the course of the study.
• •16. Incarcerated at the time of study enrollment.
• •17. Current participation in an investigational study that may impact study outcomes.
• •18. Involved in current or pending litigation regarding a spine surgery.
• •19. Receiving worker's compensation.