PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL STUDY REGISTRY ON (B)(6) 2024 FOR AN EVENT WHICH STARTED ON (B)(6) 2021. A 68-YEAR OLD FEMALE WITH PERIPHERAL VASCULAR DISEASE AND DIABETES WAS TREATED FOR A TRAUMATIC BIMALLEOLAR ANKLE FRACTURE ON (B)(6) 2021 WITH OPEN REDUCTION AND INTERNAL FIXATION, USING AN ILLUMINOSS IMPLANT, AND TWO SCREWS. THE USER REPORTED THAT STARTING IN (B)(6) 2021, THE PATIENT EXPERIENCED A CHRONIC WOUND ON THE MEDIAL SITE OF THE ANKLE. AT THE SIX MONTH FOLLOWUP VISIT ON (B)(6) 2021, THE PATIENT'S CHRONIC OSTEOMYELITIS OF THE LEFT ANKLE WAS TREATED WITH SURGICAL INTERVENTION, IN WHICH THE HARDWARE FROM THE MEDIAL MALLEOLUS WAS REMOVED, THE WOUND DEBRIDED, AND THE BIOLOGIC DRESSING CHANGED. AT A FOLLOW UP (B)(6)2022 THE USER REPORTED THAT THE PATIENT HAS BEEN NON-WEIGHT BEARING TO THE LOWER EXTREMITY, THE WOUND APPEARS SMALLER, AND PATIENT STILL DOING WET TO DRY DRESSING.

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: NO DEVICE WAS RETURNED FOR EVALUATION; AS AT THE TIME OF THIS REPORT, IT IS BELIEVED TO REMAIN IMPLANTED. DHR REVIEW: A REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THIS IMPLANT WAS A SINGLE USE, STERILE DEVICE, AND THAT THE DEVICE WAS IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. REVIEW OF IFU: A REVIEW OF THE DEVICE LABELING AND INDICATIONS FOR USE FOUND THAT THE DEVICE WAS USED TO TREAT AN ANATOMY (FIBULA) THAT IS WITHIN ITS INTENDED INDICATIONS. INSTRUCTIONS FOR USE (B)(4) WAS REVIEWED. THE RISK OF INFECTION, INCLUDING WOUND COMPLICATIONS, 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.

Additional Manufacturer Narrative

RETURNED PRODUCT EVALUATION: NO DEVICE WAS RETURNED FOR EVALUATION; AS AT THE TIME OF THIS REPORT, IT IS BELIEVED TO REMAIN IMPLANTED. DHR REVIEW: A REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THIS IMPLANT WAS A SINGLE USE, STERILE DEVICE, AND THAT THE DEVICE WAS IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. REVIEW OF IFU: A REVIEW OF THE DEVICE LABELING AND INDICATIONS FOR USE FOUND THAT THE DEVICE WAS USED TO TREAT AN ANATOMY (FIBULA) THAT IS WITHIN ITS INTENDED INDICATIONS. INSTRUCTIONS FOR USE 900365 WAS REVIEWED. THE RISK OF INFECTION, INCLUDING WOUND COMPLICATIONS, 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. THE INFORMATION WAS SUBSEQUENTLY REVIEWED WITH OUR CLNIICAL ADVISOR WHO CONCLUDED THE FOLLOWING BASED ON THE INFORMATION: THE INITIAL CONSTRUCT MAY HAVE BEEN UNSTABLE WITH AN OCCULT SYNDESMOTIC INJURY. ALTHOUGH AN EXTERNAL ROTATION STRESS TEST WAS NOTED AS HAVING BEEN PERFORMED, THE OP REPORT STATES THAT THERE WAS "]MINIMAL CLEAR SPACE WIDENING". THIS IS SOMEWHAT UNCLEAR IN THAT THERE SHOULD BE NO MEDIAL CLEAR SPACE WIDENING ON THE EXTERNAL ROTATION STRESS TEST. ADDITIONALLY, THE MORTISE VIEW X-RAY FROM (B)(6) 2021 (75 DAYS POST OP) SHOWS BOTH SYNDESMOTIC AND MEDIAL CLEAR SPACE WIDENING. THE LATERAL MALLEOLUS FRACTURE AND THE ILLUMINOSS DEVICE APPEAR TO BE INTACT. AS THE CONSTRUCT COLLAPSED, THE MEDIAL SKIN WAS PULLED OVER THE SCREW HEADS, PUTTING PRESSURE ON THE SKIN FROM THE INSIDE OUT. THIS EVENTUALLY CREATED THE CHRONIC WOUND AND SUBSEQUENT PERSISTENT INFECTION. THERE DOES NOT APPEAR TO BE AN ILLUMINOSS DEVICE FAILURE WHICH CAUSED THIS COMPLAINT, AS THE DEVICE APPEARS TO HAVE BEEN PROPERLY DEPLOYED AND INTACT. THE ROOT CAUSE IS INSUFFICIENT INITIAL FIXATION. PATIENT COMORBIDITIES OF DIABETES AND VASCULAR DISEASE MAY ALSO HAVE CONTRIBUTED IN THE FORM OF NEUROPATHY WITH DIMINISHED SENSATION AND PAIN PERCEPTION. BMI AND NONCOMPLIANCE WITH WEIGHT BEARING INSTRUCTIONS COULD ALSO BE CONSIDERED FOR CONTRIBUTING FACTORS.

Description of Event or Problem

AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL STUDY REGISTRY ON MARCH 19, 2024 FOR AN EVENT WHICH STARTED ON MARCH 8, 2021. A 68-YEAR OLD FEMALE WITH PERIPHERAL VASCULAR DISEASE AND DIABETES WAS TREATED FOR A TRAUMATIC BIMALLEOLAR ANKLE FRACTURE ON (B)(6) 2021 WITH OPEN REDUCTION AND INTERNAL FIXATION, USING AN ILLUMINOSS IMPLANT, AND TWO SCREWS.THE USER REPORTED THAT STARTING IN (B)(6) 2021, THE PATIENT EXPERIENCED A CHRONIC WOUND ON THE MEDIAL SITE OF THE ANKLE. AT THE SIX MONTH FOLLOWUP VISIT ON (B)(6)2021, THE PATIENT'S CHRONIC OSTEOMYELITIS OF THE LEFT ANKLE WAS TREATED WITH SURGICAL INTERVENTION, IN WHICH THE HARDWARE FROM THE MEDIAL MALLEOLUS WAS REMOVED, THE WOUND DEBRIDED, AND THE BIOLOGIC DRESSING CHANGED. AT A FOLLOW UP (B)(6) 2022 THE USER REPORTED THAT THE PATIENT HAS BEEN NON-WEIGHT BEARING TO THE LOWER EXTREMITY, THE WOUND APPEARS SMALLER, AND PATIENT STILL DOING WET TO DRY DRESSING.