Radiographs depicting a tulip separation at s2 were received and confirmed the event.The subject iliac screw and tulip head were returned for evaluation.The evidence of final tightening suggested that the screw was at max angulation and rod was unevenly normalized in the head of the screw.The rod created wear marks inside the screw head suggesting the lock screw and rod had loosened (may have not reached final tightening) prior to the head disassembling from the screw shank.Device was not revised for two additional years until unrelated hardware failure occurred (l1-l2) prompting unrelated revision surgery in on (b)(6) 2022.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, or patient compliance with post-operative care instructions or patient trauma/impact /sustained a fall (patient fall was reported in 2020).Root cause or specific failure mode cannot be determined.Labeling review notes: "possible adverse events.2.Disassembly, bending, and/or breakage of any or all of the components.3.Loss of fixation.".
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