BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2932251 · Received January 25, 2013

    Report

    Report Number
    3004485144-2013-00003
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 3, 2012
    Manufacturer
    LANX, INC
    Product Code
    MNI
    PMA / PMN Number
    071877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO TESTING METHODS PERFORMED (RELATED DEVICE WAS NOT RETURNED TO MANUFACTURER). RESULTS: NO RESULTS AVAILABLE SINCE NO EVAL PERFORMED (RELATED DEVICE WAS NOT RETURNED TO MANUFACTURER).

    Description of Event or Problem · 1

    A REVISION SURGERY WAS PERFORMED TO REMOVE A PREVIOUSLY IMPLANTED LANX INTERSPINOUS PROCESS DEVICE TO ADDRESS A MIGRATED NON-LANX ALLOGRAFT. SCREWS AND RODS WERE IMPLANTED IN PLACE OF THE REMOVED LANX INTERSPINOUS PROCESS DEVICE. THE SURGEON INDICATED THAT THE LANX DEVICE DID NOT MIGRATE. THERE IS NO INFO TO SUGGEST THAT THE LANX DEVICE CAUSED OR CONTRIBUTED TO THE MIGRATION OF THE NON-LANX ALLOGRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36180 LANX SPINAL FIXATION SYSTEM INTERSPINOUS PROCESS SPINAL SYSTEM MNI LANX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1