BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPUS MAGNUM2 IMPLANT KNOTLESS FIXATION DEVICE

    MDR report key: 1943739 · Received December 17, 2010

    Report

    Report Number
    2032380-2010-00033
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    October 21, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    MBI
    PMA / PMN Number
    K042914
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS AND A F/U REPORT WILL BE PROVIDED AFTER THE INVESTIGATION HAS BEEN COMPLETED. THREE ADD'L DEVICES WERE USED IN THE SAME PROCEDURE AND WERE FILED UNDER MDR 2032380-2010-00030, 2032380-2010-00031, AND 2032380-2010-00032. (B)(4).

    Description of Event or Problem · 1

    A CLINICAL INCIDENT INVOLVING FOUR OPUS MAGNUM2 IMPLANTS WAS REPORTED TO ARTHROCARE CORP. REPORTEDLY ALL DEVICES FAILED WHEN CINCHING SUTURE, WHICH CAUSED A SIGNIFICANT DELAY IN SURGERY OF 45 MINUTES TO AN HOUR. REPORTEDLY THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPUS MAGNUM2 IMPLANT KNOTLESS FIXATION DEVICE FASTENER, FIXATION, NONDEGRADABLE, SOFT MBI ARTHROCARE CORP. 1007571

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other