BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOUNTAINEER OC PLATE, SMALL

    MDR report key: 2100685 · Received May 18, 2011

    Report

    Report Number
    1526439-2011-00078
    Event Type
    Injury
    Date Received
    May 18, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K042508
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGES WERE NOT PROVIDED TO CONFIRM THE REPORTED BREAKAGE OF THE OC PLATE. THE TABS ON THE PLATE CAN BE BENT (15-DEGREES) TO FIT PATIENT ANATOMY. CARE SHOULD BE TAKEN NOT TO OVER BEND (BEYOND THE RECOMMENDED 15-DEGREES) THE PLATE. THE PLATE REMAINS IN VIVO AND NO EVALUATION CAN BE PERFORMED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IMPLANT WAS REPORTED TO HAVE FRACTURED AFTER SURGERY. IN (B)(6) 2011, O-T2 INSTRUMENTATION WAS PERFORMED. IN THE ROUTINE FOLLOW-UP THE PLATE WAS FOUND FRACTURED IN X-RAY. THE PATIENT'S CONDITION IS CURRENTLY BEING MONITORED. NO REVISION IS PLANNED AT THIS TIME. AS THIS COULD RESULT IN THE NEED FOR SURGICAL INTERVENTION AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOUNTAINEER OC PLATE, SMALL SPINAL FIXATION DEVICE KWP DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention