The reported event that could be confirmed, based on available medical record and information provided in complaint.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.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed: after reviewing surgeon¿s feedback and sterility test reports we can conclude that patient is suffering from bacterial infection caused by psuedomonas and mrsa.Also, a huge anterior wound and a posteromedial draining sinus was observed in patient.After device explant couple of procedures were performed and finally surgeon confirmed that patient is healing and doing well.Infections are often caused by a multitude of factors such as comorbidity of the patient, the trauma, the surgical intervention and the aftercare.Also, we could not find any non conformance associated with sterilization.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, bacterial infection is confirmed.If the device is returned or any further information is provided, the investigation report will be reassessed.
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