ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

BASED ON THE PATIENT'S MEDICAL CONDITION WHICH WAS REPORTED AS MULTIPLE MYELOMA WHICH IS A DISEASE THAT WEAKENS BONE, THERE APPEARS TO BE A DELAYED UNION OF THE FRACTURE. BECAUSE THE BONE WAS NOT HEALING, THE IMPLANT WAS UNDER CONTINUAL STRESS FOR A PERIOD OF THREE AND A HALF MONTHS. THIS CONTINUAL MOVEMENT EVENTUALLY WEAKENED THE IMPLANT AT THE FRACTURE SITE WHICH LED TO IT BREAKING. AS INDICATED IN THE RISK SECTION OF THE PRODUCT'S IFU (INSTRUCTIONS FOR USE), THE FOLLOWING CAN OCCUR: 'LOOSENING, BENDING, CRACKING OR FRACTURE OF THE COMPONENTS OR LOSS OF FIXATION IN BONE ATTRIBUTABLE TO DELAYED UNION, NONUNION, INSUFFICIENT QUANTITY OR QUALITY OF BONE OR MARKEDLY UNSTABLE COMMINUTED FRACTURES.'

Description of Event or Problem

(B)(6) 2019: ONCOLOGY VISIT C/O ARM PAIN NO REPORT OF TRAUMA CYCLE 4 DAY 1 VELCADE/DEX, ON ARANESP (B)(6) 2019: ORTHO OFFICE VISIT DELAYED UNION AT THE FRACTURE SITE WHICH HAS CREATED A FATIGUE FRACTURE OF THE IMPLANT. LIKELY DUE TO COMBINATION OF LOCAL TUMOR AND SYSTEMIC THERAPY. PLACED IN HUMERAL CLAMSHELL FRACTURE BRACE. RE-EVALUATION IN 2 MONTHS. IMAGING: MRI ((B)(6) 2019) EXTREMELY LIMITED EVALUATION AS OUTLINED ABOVE WITH FINDINGS FOR FRACTURE OF THE PATIENT'S INTRAMEDULLARY ROD IN ITS MID THIRD WHERE THERE IS EVIDENCE OF ANGULATION OF THE HUMERUS. HUMERUS 2 VIEWS ((B)(6) 2019) AN UNDERLYING PATHOLOGIC FRACTURE, IS PRESENT, INVOLVING THE PROXIMAL ASPECT OF THE DISTAL THIRD OF THE RIGHT HUMERUS, WITH ANTEROLATERAL ANGULATION.