BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM

    MDR report key: 9411108 · Received December 4, 2019

    Report

    Report Number
    3006845464-2019-00007
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    October 21, 2019
    Report Date
    December 3, 2019
    Manufacturer
    ILLUMINOSS MEDICAL INC
    Product Code
    QAD
    PMA / PMN Number
    K181228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203613 ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM INVIVO INTRAMEDULLARY FIXATION ROD QAD ILLUMINOSS MEDICAL INC 3804277R

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention