PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

A MEDICAL OVERSIGHT REVIEW MEETING WAS CONDUCTED WITH A MEDICAL REVIEWER, ALONG WITH CLINICAL, ENGINEERING, QUALITY AND REGULATORY REPRESENTATIVES. THE TEAM REVIEWED X-RAYS OF THE RIGHT ARM, AND THE MEDICAL REVIEWER WAS ABLE TO DETERMINE THAT AT THE PINCH POINT OF THE LESION IT APPEARED THAT SUFFICIENT REAMING WAS NOT PERFORMED. THIS CAUSED IMPLANT NARROWING DUE TO METASTATIC MATERIAL THAT PREVENTED THE BALLOON FROM FILLING OUT COMPLETELY. THE MEDICAL REVIEWER NOTED THAT THE PATIENT MAY HAVE USED THEIR ARMS TO STAND UP FROM A CHAIR AND THAT COULD BE ENOUGH TO CAUSE THE IMPLANT TO BREAK. THE MEDICAL REVIEWER ALSO NOTED THAT THE ACTUAL IMPLANT DIAMETER AT THE SITE OF THE METASTATIC LESION WAS APPROXIMATELY 11MM TO 12MM WHICH IS LESS THAN THE 13MM MINIMUM REQUIRE FOR STANDALONE USE IN THE HUMERUS PER IFU 900535 REV E. THE MEDICAL REVIEWER CONCLUDED THAT THE TUMOR MATERIAL IN INTERMEDULLARY CANAL WAS NOT MANAGED PROPERLY DUE IN PART TO NOT PERFORMING APPROPRIATE REAMING OF THE CANAL. THIS RESULTED IN IMPLANT SIZE GOING BELOW THE MINIMUM DIAMETER REQUIREMENT AND BEING SHIFTED AWAY FROM LESION RESULTING IN A WEAK SPOT ON THE IMPLANT LEADING TO EVENTUAL IMPLANT BREAK.

Description of Event or Problem

ON (B)(6) 2025, THE IMPLANT WAS INSERTED FOR INTRAMEDULLARY STABILIZATION DUE TO OSTEOLYSIS OF THE PROXIMAL HUMERUS. INCREASING PAIN AND SWELLING IN THE UPPER ARM. ACCORDING TO THE PATIENT, THERE WAS NO WEIGHT BEARING ON THE ARM. HE ALSO DID NOT FALL. ON (B)(6) 2025 THE UPPER ARM WAS X-RAYED, AND THE FRACTURE OF THE IMPLANT AND A 45-DEGREE AXIAL DEVIATION WERE DETECTED. THE PATIENT WILL NOT BE REVISED. HE WILL ONLY RECEIVE AN EXTERNAL SPLINT. PROGRESSION OF TUMOR DISEASE. METASTATIC GASTRIC CARCINOMA IN A 62 YO, 80KG MALE PATIENT.