BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 3131226 · Received May 23, 2013

    Report

    Report Number
    3004485144-2013-00016
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    May 22, 2013
    Manufacturer
    LANX, LLC
    Product Code
    MNI
    PMA / PMN Number
    071877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO TESTING METHODS PERFORMED (RELATED DEVICE WAS NOT RETURNED.) LABELING EVAL PERFORMED. THE IFU NOTES SPINOUS PROCESS FRACTURE AS A POSSIBLE SURGICAL COMPLICATION. RESULTS: NO RESULTS AVAILABLE SINCE NO EVAL PERFORMED (RELATED DEVICE WAS NOT RETURNED). CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED A SPINOUS PROCESS FRACTURE APPROX ONE MONTH AFTER A LANX INTERSPINOUS PROCESS DEVICE WAS IMPLANTED. THE SURGEON INTENDS TO PERFORM A REVISION SURGERY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230065 LANX SPINAL FIXATION SYSTEM INTERSPINOUS PROCESS SPINAL SYSTEM MNI LANX, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1