BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2890959 · Received December 20, 2012

    Report

    Report Number
    3004485144-2012-00042
    Event Type
    Other
    Date Received
    December 20, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 17, 2012
    Manufacturer
    LANX, LLC
    Product Code
    MNI
    PMA / PMN Number
    071877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: RELATED DEVICE WAS NOT RETURNED TO MFR., LABELING EVAL PERFORMED. THE IFU INDICATES INFECTION AS A POSSIBLE SURGICAL COMPLICATION. RESULTS - RELATED DEVICE WAS NOT RETURNED TO MFR. WHILE IT IS NOT BELIEVED THAT THE INTERSPINOUS PROCESS FIXATION DEVICE CONTRIBUTED TO THIS EVENT, IT CANNOT BE ABSOLUTELY CONCLUDED THAT IT DID NOT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT REVISION SURGERY TO ADDRESS AN INFECTION NEAR THE ORIGINAL SURGICAL SITE. THE INTERBODY AND SPINOUS PROCESS FIXATION DEVICES WERE REMOVED AND REPLACED WITH COMPETITIVE DEVICES. THE SURGEON DOES NOT BELIEVE THAT THESE DEVICES LED TO THE INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INTERBODY DEVICE| LANX INTERVERTEBRAL BODY VBR FUSION SYSTEM