BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIX-A LUMBAR INTEGRATED FUSION SYSTEM

    MDR report key: 6172533 · Received December 13, 2016

    Report

    Report Number
    3005031160-2016-00099
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Report Date
    December 13, 2016
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    OVD
    PMA / PMN Number
    K133947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    AN ALIF WAS PERFORMED AT L5, DATE NOT PROVIDED. DISCOVERED UPON FOLLOW-UP VISIT, AT UNKNOWN DATE, THE PATIENT EXPERIENCED A SCREW BACKOUT AND BREAKAGE. SURGEON DECIDED TO NOT PERFORM ANY ADDITIONAL SURGERY AS PATIENT IS NOT IN ANY PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820058 IRIX-A LUMBAR INTEGRATED FUSION SYSTEM INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL OVD X-SPINE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other