BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAGNUM KNOTLESS IMPLANT

    MDR report key: 703372 · Received April 21, 2006

    Report

    Report Number
    2032380-2006-00010
    Event Type
    Other
    Date Received
    April 21, 2006
    Date of Event
    March 22, 2006
    Report Date
    April 19, 2006
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HTY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON USED THREE OPUS MAGNUM KNOTLESS IMPLANTS FOR A ROTATOR CUFF REPAIR PERFORMED 03/09/06. APPROXIMATELY 2 WEEKS POSTOP. PATIENT PRESENTED WITH SHOULDER PAIN. SURGEON DETERMINED THAT ONE IMPLANT HAD COME LOOSE FROM THE BONE HOLE. SECOND SURGERY WAS PERFORMED ON MARCH 24, 2006. ONE OPUS MAGNUM ACHOR WAS EXPLANTED AND REPLACED WITH A NEW ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNUM KNOTLESS IMPLANT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE HTY ARTHROCARE CORP. NA 108808

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention