PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL REGISTRY ON 19 MARCH 2024, WHICH REPORTED AN ADVERSE EVENT STARTING 29 JULY 2021. A 76 YEAR OLD FEMALE WAS TREATED FOR A TRAUMATIC FRACTURE OF THE RIGHT HUMERUS WITH AN ILLUMINOSS IMPLANT, AND A SLING, ON 29 JULY 2021, THE USER REPORTED INTERNAL WORSENING OF THE DISPLACEMENT OF THE FRACTURE AND A BREAK IN THE ILLIMINOSS IMPLANT. ON 19 AUGUST 2021 THE USER REPORTED A FURTHER WORSENING OF THE ALIGNMENT. ON (B)(6) 2021 THE USER PERFORMED OPEN REDUCTION AND INTERNAL FIXATION WITH 2 PLATES AND SCREWS WITH THE ORIGINAL ILLUMINOSS IMPLANT. AT A FOLLOW-UP VISIT ON (B)(6) 2021, THE HARDWARE WS INTACT , AND UNCHANGED IN POSITION. ALIGNMENT WAS STABLE. AT THE 6 MONTH FOLLOW UP VISIT ON 17 MARCH 2022, USER NOTED PROGRESSING HEALING ACROSS THE FRACTURE, WITH INTACT AND STABLE ALIGNMENT.

Additional Manufacturer Narrative

RETURNED PRODUCT EVALUATION: DEVICE EVALUATION IN THIS CASE WAS NOT POSSIBLE AS THIS REPORT WAS FOR EVENTS IN 2021 AND NO DEVICE RETURN WAS POSSIBLE. DHR REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOUND THAT THE DEVICE WAS MET ALL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND RELEASE. A REVIEW OF THE IFU: A REVIEW OF THE DEVICE LABELING AND INDICATIONS FOR USE FOUND THAT THE DEVICE WAS USED TO TREAT AN ANATOMY (HUMERUS) THAT IS WITHIN THE INTENDED INDICATIONS. INSTRUCTION FOR USE (B)(4) WAS REVIEWED. THE RISK OF INADEQUATE OR LOSS OF FIXATION, AND POSSIBLE IMPLANT FRACTURE ATTRIBUTABLE TO INSUFFICIENT INTERPIAL FIXATION, IS INCLUDED IN LABELING. X-RAYS: THE FIRM REQUESTED AND RECEIVED XRAYS FROM THE USER, AND HOSTED AN INTERNAL MEDICAL OVERSIGHT REVIEW OF THE CASE INFORMATION KNOWN, AS WELL AS THESE MEDICAL RECORDS. BASED ON A REVIEW OF THE XRAYS AVAILABLE, THE MEDICAL REVIEWER NOTED THAT THE XRAYS SHOWS THAT THE FRACTURE WAS NOT FULLY REDUCED AND THERE WAS A GAP AT THE FRACTURE SITE AND THEREFORE REMAINED UNSTABLE WHICH IN TURNED CAUSED THE IMPLANT TO FAIL. THE CONCLUSION WAS THAT THE IMPLANT WAS UNSTABLE AT THE START DUE TO POOR REDUCTION. CONCLUSION: THE CAUSE OF THE ILLUMINOSS BREAK ANS LOSS OF FIXATION AND STABILIZATION IS DUE TO THE POOR FRACTURE REDUCTION IN WHICH THERE WAS A GAP AT THE FRACTURE SITE, CAUSING A STRESS RISER IN THE IMPLANT.

Additional Manufacturer Narrative

AT THE TIME OF THIS INITIAL MDR REPORT, THE INVESTIGATION INTO THE CAUSE OF THE EVENT IS STILL ONGOING. RETURNED PRODUCT EVALUATION: DEVICE EVALUATION IN THIS CASE IS NOT POSSIBLE AS THIS REPORT WAS FOR EVENTS IN 2021, AND NO DEVICE RETURN WAS POSSIBLE. DHR REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE HAS NOT YET BEEN POSSIBLE AS THE DEVICE IDENTIFICATION INFORMATION WAS NOT INITIALLY PROVIDED TO THE MANUFACTURER, HOWEVER WE HAVE REQUESTED THIS INFORMATION AND ANTICIPATE PERFORMING A REVIEW OF THE MANUFACTURING RECORDS. REVIEW OF IFU. A REVIEW OF THE DEVICE LABELING AND INDICATIONS FOR USE FOUND THAT THE DEVICE WAS USED TO TREAT AN ANATOMY (HUMERUS) THAT IS WITHIN ITS INTENDED INDICATIONS. INSTRUCTIONS FOR USE 900365 WAS REVIEWED. THE RISK OF INADEQUATE OR LOSS OF FIXATION, AND POSSIBLE IMPLANT FRACTURE, IS INCLUDED IN THE LABELING. X-RAYS: THE FIRM REQUESTED AND RECEIVED X-RAYS FROM THE USER, AND HOSTED AN INTERNAL MEDICAL OVERSIGHT REVIEW OF THE CASE INFORMATION KNOWN, AS WELL AS THESE MEDICAL RECORDS. THE FIRM IDENTIFIED FOLLOWUP INFORMATION REQUESTS TO THE USER, WHICH WILL SUPPORT SUBSEQUENT ANALYSIS FOR THE FIRM'S ROOT CAUSE INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FURTHER INFORMATION IS KNOWN ABOUT THIS CASE.

Description of Event or Problem

AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL REGISTRY ON 19 MARCH 2024, WHICH REPORTED AN ADVERSE EVENT STARTING 29JUL2021. A 76 YEAR OLD FEMALE WAS TREATED FOR A TRAUMATIC FRACTURE OF THE RIGHT HUMERUS WITH AN ILLUMINOSS IMPLANT, AND A SLING, ON (B)(6) 2021. ON (B)(6) 2021 THE USER REPORTED INTERNAL WORSENING OF DISPLACEMENT OF THE FRACTURE. ON (B)(6) 2021 THE USER REPORTED A FURTHER WORSENING OF THE ALIGNMENT. BETWEEN (B)(6) 2021 THE USER REPORTS TO HAVE FOUND THE IMPLANT FRACTURED, AND THE PATIENT TREATED WITH SURGICAL INTERVENTION. THE USER PERFORMED OPEN REDUCTION AND INTERNAL FIXATION WITH 2 PLATES AND SCREWS WITH ILLUMINOSS IMPLANT. AT A FOLLOW UP VISIT ON (B)(6) 2021, THE HARDWARE WAS INTACT, AND UNCHANGED IN POSITION. ALIGNMENT WAS STABLE. AT THE 6 MONTH FOLLOW UP ON (B)(6) 2022, USER NOTED PROGRESSING HEALING ACROSS THE FRACTURE, WITH INTACT AND STABLE ALIGNMENT.