BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEOPARD CURVED 7MM WEDGED VBR, 5 DEGREES

    MDR report key: 1586580 · Received January 12, 2010

    Report

    Report Number
    1526439-2010-00002
    Event Type
    Malfunction
    Date Received
    January 12, 2010
    Date of Event
    December 15, 2009
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K03168
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF CAGE BREAKAGE CANNOT BE POSITIVELY DETERMINED AS THE DEVICE IS NOT AVAILABLE FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE DEVICE LOT CODE IS UNK. HOWEVER, IT IS LIKELY THAT THE APPLICATION OF ATYPICAL FORCE UPON THE CAGE DURING REPOSITIONING RESULTED IN THE BREAKAGE OF THE DEVICE. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT AFTER INITIAL PLACEMENT, THE SURGEON TRIED TO MOVE THE CAGE TO A MORE POSTERIOR POSITION USING A REMOVAL INSTRUMENT AND THE CAGE BROKE INTO PIECES. A PORTION OF THE CAGE COULD NOT BE REMOVED AND REMAINS IN THE PT. ANOTHER CAGE WAS USED TO COMPENSATE THE LEFT VERTEBRAL SPACE. THE DIFFICULTY PROLONGED THE SURGICAL PROCEDURE BY EIGHTY FIVE MINUTES. AS THE CAGE BREAKAGE RESULTED IN AN UNINTENDED PORTION OF THE DEVICE REMAINING IN THE PT AND IN A SIGNIFICANT DELAY TO THE SURGICAL PROCEDURE, A MEDWATCH REPORT IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEOPARD CURVED 7MM WEDGED VBR, 5 DEGREES SPINAL VERTEBRAL BODY REPLACEMNT DEVICE MAX DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female STAPLE REMOVER: (B) (4)| STAPLE REMOVER: (B) (4)