Correction - h6 (clinical signs code, device code, results code and conclusion code).The complaint could be confirmed, since the information for evaluation matches the alleged failure, as a revision could be confirmed based on implant loosening, but a implant breakage could not be confirmed based on the received information.Upon further investigation of the ct scans by healthcare professionals the following was observed: there is clear radiolucence and smaller anterior cysts.These findings suggest loosening.There is no clear sign of migration visible.The implant is in an intact condition.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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