Review of device history records show that lot released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The user facility refused to return the requested implant, however, post-operative scans were available and are being reviewed by the quality engineering team.There is currently no indication that the product was manufactured outside specifications determined by the patient's initial pre-operative ct scans.No non-conformances were identified during the manufacture of this implant.This product is manufactured for one particular patient only based on their anatomy at the time of the ct scan.As anatomy and tissue can change over time, the instructions for use (ifu) that accompanies the distribution of this product indicates that some modifications may be required.The design and manufacturing processes have been reviewed and no discrepancies or non-conformances have been identified.The user facility is foreign; therefore, a facility medwatch report will not be available.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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