Correction - b5, h6 (clinical code, device code, results code, conclusion code).The reported event could be confirmed, since images of ct scans were provided and matches the alleged failure mode.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by the presence of osteolysis/cysts in the bone.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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