OMNIPORE SURGICAL IMPLANT

Additional Manufacturer Narrative

ACCORDING TO THE INITIAL REPORT, A PATIENT IS UNDERGOING A SURGERY REVISION DUE TO AN EAR IMPLANT FRACTURE. THE DATE OF THE SURGERY IS UNKNOWN. REQUESTS FOR ADDITIONAL INFORMATION WERE MADE TO NO AVAIL. AS THE LOT NUMBER OF THE PRODUCT IS UNKNOWN, MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL DETAILS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

Description of Event or Problem

ACCORDING TO THE INITIAL REPORT, THE SURGEON STATED THAT A PATIENT EXPERIENCED AN IMPLANT FRACTURE AND NEEDED A REPLACEMENT FOR SURGICAL INTERVENTION.