BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPUS MAGNUM2 IMPLANT KNOTLESS FIXATION DEVICE

    MDR report key: 2011754 · Received March 3, 2011

    Report

    Report Number
    2032380-2011-00013
    Event Type
    Other
    Date Received
    March 3, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ARTHROCARE CORP
    Product Code
    MBI
    PMA / PMN Number
    K042914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE DEVICE WILL BE RETURNED FOR INVESTIGATION. TO DATE THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE INVESTIGATION AND LOT HISTORY REVIEW ARE COMPLETED. THE THREE ADDITIONAL DEVICES USED IN THE SAME PROCEDURE WERE FILED UNDER MDR 2032380-2011-00011, 2032380-2011-00012, AND 2032380-2011-00014. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED TO ARTHROCARE THAT A PT UNDERWENT AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2011 USING FOUR OPUS MAGNUM2 IMPLANTS. ALLEGEDLY THE WIRE BROKE WHEN REELING THE SUTURE INTO THE BONE ANCHOR OUTSIDE OF THE SHOULDER JOINT. THE PHYSICIAN REVERTED TO A MINI-OPEN PROCEDURE AND USED AN ALTERNATE DEVICE (NON ARTHROCARE DEVICE) TO COMPLETE THE PROCEDURE. PT WAS REPORTED AS DOING WELL, HEALING PROCESS WAS OPTIMAL, AND THE PT WAS DISCHARGED FROM HOSPITAL.

    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 2106324

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other