BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1504536 · Received October 9, 2009

    Report

    Report Number
    3004485144-2009-00007
    Event Type
    Injury
    Date Received
    October 9, 2009
    Report Date
    September 11, 2009
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE ATTEMPTS, LANX WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM THE DISTRIBUTOR REPRESENTATIVE AND SURGEON. AT THIS TIME, THERE IS INSUFFICIENT INFORMATION TO DRAW A CONCLUSION FOR THE REPORTED EVENT(S). BASED ON THE INITIAL REPORT FROM THE DISTRIBUTOR REPRESENTATIVE, THERE IS NO INFORMATION TO SUGGEST THAT THE DEVICE MALFUNCTIONED OR FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPRESENTATIVE REPORTED THAT A REVISION SURGERY WAS PERFORMED ON TWO DIFFERENT PATIENTS, BECAUSE A LANX SPINAL FIXATION DEVICE LOOSENED. LANX WAS UNABLE TO OBTAIN DETAILS OF THE EVENTS. AT THIS TIME, THERE IS NO INFORMATION TO SUGGEST THE IMPLANTS MALFUNCTIONED OR FAILED TO MEET PERFORMANCE SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention