A Post Market Surveillance on INFUSE Bone Graft

Exclusion Criteria16

• 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