A Post Market Surveillance on INFUSE Bone Graft

Exclusion Criteria

• •Has a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation
• •Has any active malignancy or undergoes treatment for a malignancy, or operative site is in the vicinity of a resected or extant tumor
• •Is skeletally immature (\<18 years of age or no radiographic evidence of epiphyseal closure)
• •Is pregnant or lactating
• •Has an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone
• •The use of the Infuse™ Bone Graft component implanted at locations other than the lower lumbar spine (e.g., cervical spine)
• •Repeat applications of the Infuse™ Bone Graft component
• •Has up to Grade 1 retrolisthesis
• •Has hepatic or renal impairment
• •Has metabolic bone disease
• •Has autoimmune disease
• •Has immunosuppressive disease or suppressed immune systems resulting from radiation therapy, chemotherapy, steroid therapy, or other treatments
• •Is illiterate or vulnerable (e.g., the participant is incapable of judgment or is under tutelage) as per the investigator's assessment
• •Concurrent participation in another clinical study that may confound study results
• •Has a considerable risk for surgery
• •Has a condition that could compromise study (e.g., mentally incompetent, alcohol or drug abuse) as per the investigator's assessment