BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2625859 · Received June 7, 2012

    Report

    Report Number
    3004485144-2012-00021
    Event Type
    Other
    Date Received
    June 7, 2012
    Date of Event
    May 15, 2012
    Report Date
    May 17, 2012
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    PMA / PMN Number
    043484
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. IT ALSO CAUTIONS THAT DETERIORATION OF THE DEVICE AFTER BONE CONSOLIDATION CANNOT BE CONSIDERED TO CONSTITUTE A DYSFUNCTION OR DETERIORATION IN THE CHARACTERISTICS OF THE IMPLANTS.

    Description of Event or Problem · 1

    DURING A PLANNED HARDWARE REMOVAL, A PEDICLE SCREW AT S1 WAS DISCOVERED AS BEING BROKEN BENEATH THE TULIP HOUSING; IT IS NOT KNOWN WHETHER THE FRACTURE OCCURRED DURING REMOVAL OR PRIOR TO THIS REOPERATION. THE SCREW SHANK WAS IMBEDDED IN THE PEDICLE, AND SO THE SURGEON ELECTED TO LEAVE IT IN THE PATIENT. THIS REMOVAL SURGERY TOOK PLACE OVER FOUR YEARS AFTER THE ORIGINAL IMPLANTATION AND THE PATIENT WAS COMPLETELY FUSED FROM L4-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI LANX, INC. 7715-7555 LX-1474

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention