BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 3221520 · Received July 9, 2013

    Report

    Report Number
    3004485144-2013-00023
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    September 6, 2012
    Report Date
    December 5, 2012
    Manufacturer
    LANX, INC.
    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

    A PATIENT THAT UNDERWENT A POSTERIOR LUMBAR FUSION USING A LANX SPINOUS PROCESS FIXATION DEVICE DEVELOPED AN EPIDURAL ABSCESS WITH A PSOAS INFECTION. THE SURGEON COMPLETED A REVISION SURGERY TO ADDRESS THESE CONDITIONS, WHICH INCLUDED THE REMOVAL OF THE LANX SPINOUS PROCESS FIXATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313577 LANX SPINAL FIXATION SYSTEM INTERSPINOUS PROCESS SPINAL SYSTEM MNI LANX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR