PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT

Additional Manufacturer Narrative

THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. THE SURGEON REPORTED TO THE MANUFACTURER THAT THE CUSTOM DEVICE BROKE IN THE PATIENT FOLLOWING A WAVE IMPACT AND FALL WHILE THE PATIENT WAS AT THE BEACH. THE BROKEN DEVICE WAS EXPLANTED. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION SINCE IT WAS DISCARDED POST-EXPLANTATION. THERE IS NO FURTHER INFORMATION ON A REVISION SURGERY TO REPLACE THE DEVICE THAT WAS EXPLANTED. A SUPPLEMENTAL REPORT WILL BE FILED AS NEW INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED TO THE MANUFACTURER THAT A CUSTOM IMPLANT FRACTURED IN THE PATIENT FOLLOWING A WAVE IMPACT AND FALL WHILE AT THE BEACH. ON (B)(6) 2023, THE BROKEN IMPLANT WAS EXPLANTED. NO REVISION SURGERY HAS BEEN SCHEDULED YET WITH A NEW DEVICE TO REPLACE THE EXPLANTED CUSTOM DEVICE. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2022. NO OTHER COMPLICATIONS WERE REPORTED TO THE MANUFACTURER.