BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPUS MAGNUM IMPLANT

    MDR report key: 506825 · Received January 14, 2004

    Report

    Report Number
    2032380-2004-00001
    Event Type
    Injury
    Date Received
    January 14, 2004
    Report Date
    January 14, 2004
    Manufacturer
    OPUS MEDICAL, INC.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A FEW DAYS POST-OP THE PT EXPERIENCED SHARP PAIN IN SHOULDER. AN X-RAY OF THE SHOULDER SHOWED A PORTION OF AN IMPLANT PROTRUDING FROM THE IMPLANT SITE IN HUMERAL HEAD INTO THE INTRACAPSULAR SPACE. TWO IMPLANTS WERE UTILIZED TO ACHEIVE THE ROTATOR CUFF REPAIR AND ALTHOUGH ONLY ONE APPEARED TO BE PROBLEMATIC, THE SURGEON DECIDED TO REMOVE BOTH IMPLANTS. ON REMOVAL, THE SURGEON REPAIRED THE TORN ROTATOR CUFF WITH TWO SCREW TYPE ANCHORS USING ARTHROSCOPIC TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPUS MAGNUM IMPLANT ORTHOPEADIC BONE ANCHOR MBI OPUS MEDICAL, INC. CM-1500 S0288

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R