BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 3221522 · Received July 9, 2013

    Report

    Report Number
    3004485144-2013-00022
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    March 7, 2013
    Report Date
    July 9, 2013
    Manufacturer
    LANX, LLC
    Product Code
    MNI
    PMA / PMN Number
    071877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A 2 MONTH POST-OPERATIVE FOLLOW UP, THE SURGEON NOTICED THAT THE LANX SPINOUS PROCESS FIXATION DEVICE HAD BECOME DISPLACED DORSALLY. THE SURGEON HAS RECOMMENDED THAT A REVISION SURGERY BE PERFORMED TO ADDRESS THE DISPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312289 LANX SPINAL FIXATION SYSTEM INTERSPINOUS PROCESS SPINAL SYSTEM MNI LANX, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR