BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2474183 · Received February 27, 2012

    Report

    Report Number
    3004485144-2012-00010
    Event Type
    Other
    Date Received
    February 27, 2012
    Date of Event
    February 1, 2012
    Report Date
    January 1, 2012
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    PMA / PMN Number
    043484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED INSTRUCTIONS FOR USE LISTS EARLY OR LATE IMPLANT BENDING, BREAKAGE OR FAILURE AS POSSIBLE COMPLICATIONS. THE DEVICE FAILURE MAY BE AT LEAST PARTIALLY ATTRIBUTABLE TO THE CONCOMITANT USE AND ALLEGED MALFUNCTION OF COMPETITIVE PRODUCT.

    Description of Event or Problem · 1

    THE PT UNDERWENT REVISION SURGERY TO REPLACE A PEDICLE SCREW CONSTRUCT. ONE OF THE ORIGINAL SCREWS HAD FRACTURED UNDER THE TULIP HOUSING. THE INITIAL SURGERY ALSO INVOLVED IMPLANTATION OF A TRANS1 AXIALIF DEVICE AND MEDTRONIC INFUSE BONE GRAFT. BOTH OF THESE PRODUCTS MAY HAVE CONTRIBUTED TO THE EVENT; POST-OPERATIVE MOTION OF THE AXIALIF DEVICE AND HYPERDEMINERALIZATION OF THE VERTEBRAL BODY WERE OBSERVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MEDTRONIC INFUSE BONE GRAFT| TRANS1 AXIALIF