BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPUS MAGNUN ANCHOR

    MDR report key: 385522 · Received March 29, 2002

    Report

    Report Number
    2032380-2002-00001
    Event Type
    Injury
    Date Received
    March 29, 2002
    Date of Event
    February 28, 2002
    Report Date
    March 1, 2002
    Manufacturer
    OPUS MEDICAL, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A FOLLOW-UP VISIT TO THE CLINIC AFTER ARTHROSCOPIC ROTATOR CUFF REPAIR, ONE OF FOUR BONE ANCHORS PLACED TO ATTACH THE ROTATOR CUFF TO THE HUMERAL HEAD WAS FOUND TO HAVE MOVED FROM THE IMPLANTATION SITE INTO THE INTRACAPSULAR SPACE. AS A RESULT, THE SURGEON REMOVED THE ANCHOR ARTHROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPUS MAGNUN ANCHOR ORTHOPEADIC BONE ANCHOR HTY OPUS MEDICAL, INC. OM-1000 S0055

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R