BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2436197 · Received January 17, 2012

    Report

    Report Number
    3004485144-2012-00004
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 19, 2011
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    PMA / PMN Number
    K043484
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PEDICLE SCREW INSERTION, AS PART OF A POSTERIOR LUMBAR FUSION WITH INSTRUMENTATION, THE TIPS OF TWO SCREWDRIVERS BROKE WITHIN THE PEDICLE SCREW ASSEMBLIES AND COULD NOT BE RETRIEVED. THE PT HAD VERY HARD BONE, AND THIS IS BELIEVED TO HAVE CONTRIBUTED TO THE EVENT. THE RODS WERE SUBSEQUENTLY TIGHTENED INTO THE PEDICLE SCREWS, CAPTURING THE DRIVER FRAGMENTS. THE SURGERY WAS COMPLETED, AND THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI LANX, INC. L515422

    Patients

    Seq Age Sex Outcome Treatment
    1