The reported event could be confirmed, based on available information and medical expert opinion.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Microbiologist reviewed the sterilization procedures, environmental monitoring, bioburden data and the dhr and noted: the subject device was packaged according to established design and process specifications, and was sterilized according to procedure.No deviation for a non-conformance could be found.Upon further investigation of the ct scans by healthcare professionals the following was observed "implant removed due to hematogenic infection (bacteria from another infection site in the body carried by the bloodstream to the implant).This is a patient related issue, no a device related issue." based on investigation, the root cause was attributed to a patient related issue.The failure was caused by hematogenic infection.If device is returned or any further information is provided, the investigation report will be reassessed.
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