Pelvic Fixation and Fusion During Multilevel Spinal Surgery

PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.

Inclusion Criteria:≥ 18 years of age at screening.Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuse Bedrock GranitePatient is willing and able to provide written informed consentExclusion Criteria:Any known anatomic issues or permanent implants already in the pelvis that could interfere with placement of the study device(s)Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participationKnown allergy to titanium or titanium alloysCurrent local or systemic infection that raises the risk of surgeryCurrently pregnant or planning pregnancy in the next 2 yearsKnown or suspected active drug or alcohol abuse, including opioidsPatient is a prisoner or ward of the statePatient is enrolled in an investigational clinical trial related to the spine