There is no plan for revision surgery and the device remains in situ.The device was not returned and is not available for evaluation.Image confirming the event was received depicting the fracture below the mid point of the screw.Lot number was not provided.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, 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.) root cause or specific failure mode cannot be determined.
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