BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUNTAINEER 31MM OC PLATE

    MDR report key: 2192973 · Received July 21, 2011

    Report

    Report Number
    1526439-2011-00126
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 30, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K042508
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLATES WERE IMPLANTED AND ARE NOT AVAILABLE FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCY FOR THIS LOT NUMBER. THE CAUSE OF BREAKAGE DURING BENDING OF THE PLATES CANNOT BE DETERMINED. AS NOTED IN THE SURGICAL TECHNIQUE, THE PLATE CAN BE BENT TO A MAXIMUM OF 15 DEGREES IN EITHER DIRECTION. ADDITIONALLY, TO MAINTAIN INTEGRITY OF THE OCCIPITAL IMPLANT, THE PLATE MUST BE BENT IN ONE DIRECTION ONLY. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE CRANIAL SINGLE LIMB SECTIONS OF TWO OCCIPITAL PLATES, BOTH LOT 8606N, BROKE DURING BENDING AND BEFORE BEING IMPLANTED. AFFILIATE REPORTS THAT BOTH PLATES WERE IMPLANTED AS NO OTHER PLATES WERE AVAILABLE TO THE SURGEON. NO ADVERSE OUTCOME HAS BEEN REPORTED TO DATE. AS COMPROMISED DEVICES WERE IMPLANTED, A MEDWATCH REPORT IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOUNTAINEER 31MM OC PLATE SPINAL FIXATION DEVICE KWP DEPUY SPINE, INC. NA 8606N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK