Though revision surgery occurred, the device was not returned.Device is not available for evaluation.Additionally, no event radiographs nor images of the device were provided for analysis.To date, multiple communication attempts have been made to retrieve the product information and lot number.Part number and lot number were not provided.Dhr review cannot be completed at this time.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, 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.
|