Radiographs confirming the event were received.Dhr review cannot be completed as the product has not been returned because the device remains implanted.Multiple attempts have been made to gain additional information.Patient activity at the time or prior to the event is unknown.The degree of spinal instability is unknown.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort.Review of labeling notes: warning cautions and precautions, "loosening, bending, dislocation, and/or breakage of the components, possibly requiring further surgery." the root cause of this reported event has not been determined.
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Patient's initial posterior lumbar fixation surgery reportedly occurred approximately 3 months ago (exact date unknown.) during follow up visit it was discovered that the both s1 iliac locking screws had loosened, and the rod disassociated from the iliac bone screws.Length of construct and levels treated are unknown.Patient history is unknown.Patient status is unknown.Surgeon is monitoring and is planning a revision surgery, date is unknown.
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