BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 X-TAB POLYAXIAL DRIVER

    MDR report key: 2152470 · Received June 28, 2011

    Report

    Report Number
    1526439-2011-00114
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 7, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SPINE HAS REQUESTED RETURN OF THE INSTRUMENT FOR EVAL. A F/U MEDWATCH REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE DRIVER THAT WAS PART OF AN ORTHO KIT WAS FOUND IN A TRAY ON A SHELF WITH ITS TIP SNAPPED OFF. THE VERY DISTAL TIP THAT ENGAGES IN A SCREW HEAD HAD BROKEN OFF AND THE PIECE MISSING. IT IS NOT KNOWN WHETHER A MALFUNCTION OCCURRED AS THE BREAKAGE HAD NOT BEEN REPORTED TO THE AFFILIATE. IT IS NOT KNOWN WHEN/WHERE THE TIP BREAKAGE OCCURRED. AS AN UNINTENDED PORTION OF THE DEVICE MAY HAVE BEEN LEFT EMBEDDED IN THE IMPLANT AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER2 X-TAB POLYAXIAL DRIVER INSTRUMENT, ORTHOPAEDIC, MANUAL, SURGICAL LXH DEPUY SPINE, INC. NA 0310MI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK