BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPUS MAGNUM IMPLANT

    MDR report key: 578062 · Received March 1, 2005

    Report

    Report Number
    2032380-2005-00001
    Event Type
    Injury
    Date Received
    March 1, 2005
    Date of Event
    February 1, 2005
    Report Date
    February 28, 2005
    Manufacturer
    OPUS MEDICAL, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED OPUS IN 2005 CLAIMING THAT THEY HAD FAULTY IMPLANTS PLACED INTO THEIR SHOULDER WHICH PULLED OUT OF THE BONE NECESSITATING A REVISION OF A ROTATOR CUFF REPAIR. FOLLOWING UP WITH THE ATTENDING SURGEON CONFIRMED THAT A REVISION OF THE PATIENTS ROTATOR CUFF REPAIR WAS REQUIRED AS A RESULT OF THE IMPLANTS PULLING OUT OF THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPUS MAGNUM IMPLANT ORTHOPAEDIC BONE ANCHOR HTY OPUS MEDICAL, INC. OM-1500 NOT SUPPLIED

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R