Please note the corrections made to the device code, conclusion code, and clinical code: the complaint was confirmed, since the information for evaluation matches the alleged failure.Upon further investigation of the ct scans by healthcare professionals the following was observed: the talar component also shows some radiolucence and some smaller cysts.Here, loosening can be confirmed while a clear dislocation is not visible.There is no information given, that infection is present, however, it cannot be assessed with the ct scan only.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 lot number was not communicated.Based on investigation, the root cause was attributed to a patient factors issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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