BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED 12MM WEDGED VBR, 5 DEGREES

    MDR report key: 1961673 · Received December 28, 2010

    Report

    Report Number
    1526439-2010-00190
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    November 29, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MQP
    PMA / PMN Number
    K031635
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE CONCLUSIONS CAN BE MADE AS THE DEVICE IS NOT AVAILABLE FOR EVAL AND ITS LOT CODE IS UNK. HOWEVER, CAGE BREAKAGE IS LIKELY DUE TO THE APPLICATION OF ATYPICAL FORCE UPON THE DEVICE DURING IMPACTION. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT AFTER REPOSITIONING THE CAGE DUE TO DIFFICULTY REMOVING THE INSERTION INSTRUMENT, THE POSTERIAL MEDIAL PORTION OF THE CAGE BROKE DURING IMPACTION. THE BROKEN PORTION OF THE CAGE WAS REMOVED AND THE MAJOR PORTION OF THE CAGE WAS LEFT IN PLACE. AS A COMPROMISED DEVICE WAS IMPLANTED, A MEDWATCH REPORT IS BEING SUBMITTED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED 12MM WEDGED VBR, 5 DEGREES VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK