There is no plan for revision surgery and the devices remain in situ.The devices were not returned and are not available for evaluation.Image confirming the event was received depicting the fracture near the mid point of the screw.Lot numbers were not provided.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, duration of implantation, the degree of pseudarthrosis, patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported.) these factors dictate the longevity of the implant.Root cause or specific failure mode cannot be determined.
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