PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

THE MANUFACTURER IS IN PROCESS OF INVESTIGATING THIS EVENT, AND WILL SUBMIT A FOLLOWUP REPORT WITH INVESTIGATION FINDINGS AND CONCLUSIONS, AND ANY UPDATED INFORMATION.

Description of Event or Problem

AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL STUDY REGISTRY ON (B)(6) 2022 FOR AN EVENT WHICH OCCURRED ON (B)(6) 2021. ON (B)(6) 2021, AN ILLUMINOSS IMPLANT (SIZE 17MMX280MM) WAS USED TO TREAT A PATIENT WITH A NON-TRAUMATIC IMPENDING PATHOLOGIC FRACTURE OF THE LEFT HUMERUS IN A 63 YEAR-OLD MALE PATIENT WITH MULTIPLE MYELOMA. DIAPHYSEAL, SIMPLE, TRANSVERSE, CLOSED FRACTURE. SIGNIFICANT BONE LOSS WAS NOTED BY THE TREATING PHYSICIAN AT THE TIME OF FINAL REDUCTION AND IMPLANTATION. NO DEVICES WERE USED IN CONJUNCTION WITH THE ILLUMINOSS IMPLANT. A SOFT CAST/SPLIT WAS USED POST IMPLANTATION FOR FRACTURE SUPPORT. THE ADVERSE EVENT "LOSS OF OR INADEQUATE FIXATION IN BONE" WAS OBSERVED BY THE TREATING PHYSICIAN ON (B)(6) 2022. SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS WITH ADDITIONAL FIXATION PROCEDURE IM NAILING. ALTHOUGH THE INVESTIGATION IS STILL ONGOING INTO THE CAUSE OF THE LOSS OF FIXATION, THIS INCIDENT NECESSITATED SURGICAL INTERVENTION TO ADD ADDITIONAL FIXATION (IM NAILING) TO ACHIEVE STABILIZATION OF THE ORIGINAL BONE FRACTURE, AND THEREFORE THIS INITIAL MDR IS BEING SUBMITTED.

Additional Manufacturer Narrative

NEW INFORMATION: MANUFACTURER NARRATIVE: AT THE TIME OF THE INITIAL MDR SUBMISSION FOR THIS EVENT, THE INVESTIGATION INTO THE CAUSE OF THIS EVENT WAS STILL UNDERWAY. THIS FOLLOWUP MDR IS SUBMITTED TO SUBMIT NEW INFORMATION, INCLUDING - THE INVESTIGATION FINDINGS CODES - INVESTIGATION CONCLUSION CODES - AND THIS MANUFACTURER'S NARRATIVE WITH THE FIRM'S ROOT CAUSE CONCLUSIONS. THE FIRM REVIEWED THE MANUFACTURING RECORDS FOR THIS DEVICE, AND FOUND THAT IT WAS IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. NO EVALUATION OF THE DEVICE WAS POSSIBLE AS IT REMAINED WITHIN THE PATIENT. ADDITIONAL REVIEW OF THE INFORMATION ABOUT THE CASE, MEDICAL RECORDS, AND X-RAYS WAS PERFORMED WITH MEDICAL OVERSIGHT, TO SUPPLEMENT THE COMPLAINT INVESTIGATION. ILLUMINOSS CLINICAL AND MEDICAL AFFAIRS MET WITH INDEPENDENT MEDICAL OVERSIGHT AND MADE THE FOLLOWING OBSERVATIONS: · ON THE PRE-OP X-RAYS, THE FRACTURE DOESN'T LOOK IMPENDING. THERE IS A CRACK OBSERVED MID-SHAFT AND A SHARP EDGE ON THE MEDIAL CORTEX AND A FRACTURE LINE GOING ACROSS THE BONE. · THE TREATING PHYSICIAN NOTES: SIGNIFICANT BONE LOSS WAS NOTED AT THE TIME OF FINAL REDUCTION. NO OTHER FIXATION WAS USED. A SOFT CAST/SPLIT WAS USED FOR FRACTURE SUPPORT. · THE BALLOON OF THE ILLUMINOSS IMPLANT IN THE CANAL APPEARED SUFFICIENTLY FILLED · THIS WAS A COMMINUTED FRACTURE PRIOR TO THE ILLUMINOSS IMPLANTATION. · PRE-TREATMENT, THE HUMERUS BONE HAD ABOUT A 2.5CM HOLE IN THE MIDSHAFT IN ADDITION TO THE COMMINUTED FRACTURE, WHICH WOULD MAKE THE INITIAL ILLUMINOSS IMPLANTATION UNSTABLE DUE TO THE LARGE SEGMENTAL BONE DEFECT. · THERE ARE ADDITIONAL LESIONS IN THE BONE OUTSIDE OF THE LARGE MID-SHAFT DEFECT, WHICH CONTRIBUTED TO INSTABILITY OF THE FRACTURE. · THERE WAS AN INSUFFICIENT QUANTITY OF BONE AT THE MID-SHAFT FOR THE ILLUMINOSS IMPLANT TO PROVIDE STABILITY TO, DUE TO THE BONE DEFECT. · PATIENT PRE-EXISTING MEDICAL CONDITION: IT WOULD BE UNLIKELY TO HAVE SIGNIFICANT BONE REGROWTH AT THE LESION OR FRACTURE SITE WITH MULTIPLE MYELOMA, AND BONE REGROWTH WOULD BE EVEN MORE UNLIKELY IF THE BONE WAS IRRADIATED AS A PART OF TREATMENT (IT IS UNKNOWN IF THE BONE WAS PREVIOUSLY IRRADIATED). IFU 900356 REV W WAS REVIEWED AND FOUND THAT IT CAPTURES THE RISK OF LOSS OF OR INADEQUATE FIXATION IN BONE DUE TO INSUFFICIENT QUANTITY OF BONE EXPERIENCED IN THIS COMPLAINT. "RISKS: AS WITH ANY IM FIXATION SYSTEM OR ROD THE FOLLOWING CAN OCCUR: LOOSENING, BENDING, CRACKING, FRACTURE, OR MECHANICAL FAILURE OF THE COMPONENTS OR LOSS OF OR INADEQUATE FIXATION IN BONE ATTRIBUTABLE TO DELAYED UNION, NONUNION, INSUFFICIENT QUANTITY OR QUALITY OF BONE, MARKEDLY UNSTABLE COMMINUTED FRACTURES, OR INSUFFICIENT INITIAL FIXATION." CONCLUSIONS: THE CAUSE OF THE INSTABILITY AND LOSS OF FIXATION WAS DUE TO THE SIZE OF THE LESION IN THE MIDSHAFT OF THE HUMERUS RESULTING IN AN INSUFFICIENT QUANTITY OF BONE FOR THE ILLUMINOSS IMPLANT TO PROVIDE STABILITY.