BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAGNUM KNOTLESS IMPLANT

    MDR report key: 766632 · Received October 3, 2006

    Report

    Report Number
    2032380-2006-00020
    Event Type
    Other
    Date Received
    October 3, 2006
    Date of Event
    August 8, 2006
    Report Date
    September 29, 2006
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HTY
    PMA / PMN Number
    k012125
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED ANCHOR WAS RETURNED FOR EVALUATION, A LOT NUMBER WAS NOT PROVIDED. THE SUTURE LOCK AND SUTURE WERE INTACT AND APPEARED TO HAVE BEEN SECURED BY THE SUTURE PLUG. THE TOGGLE HAS SEPARATED FROM THE ANCHOR BODY. IT CAN NOT BE DETERMINED IF THE DEFORMATION OF THE BONE LOCK TOOK PLACE AS A RESULT OF INTRACORTICAL PLACEMENT OF THE IMPLANT OR WAS RESULT OF FORCES APPLIED TO THE IMPLANT POST-SURGICALLY, NO CONCLUSION CAN BE DRAWN BASED ON CONDITION OF DEVICE AND INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IN 2006 A CALL WAS RECEIVED NOTIFYING THE COMPANY OF A REVISION SURGERY REQUIRED IN CONJUNCTION WITH A BONE ANCHOR. INFORMATION PROVIDED INDICATED THE SURGEON HAS PERFORMED A ROTATOR CUFF REPAIR ON AT EARLY DATE (NOT PROVIDED). POSTOPERATIVELY PATIENT PRESENTED WITH PAIN. A SECOND SURGERY WAS PERFORMED TO REMOVE TWO LOOSE ANCHORS. THE ROTATOR CUFF APPEARED TO BE FULLY HEALED TO BONE, THEREFORE, NO MEW ANCHORS WERE REQUIRED, SURGEON INDICATED OSTEOPOROTIC BONE QUALITY WAS EVIDENT IN THE FEMALE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention