BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARANAX ANTERIOR CERVICAL PLATING SYSTEM

    MDR report key: 6048565 · Received October 21, 2016

    Report

    Report Number
    3005031160-2016-00085
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Report Date
    September 26, 2016
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K150834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, STILL IMPLANTED WITHIN THE PATIENT. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AT THE SIX MONTH FOLLOW UP VISIT THE SURGEON TOOK X-RAY FILMS AND SAW ONE SCREW ALLEGEDLY STARTING TO BACK OUT OF THE ARANAX PLATE. THE NECK IS FUSING WELL, AND SURGEON HAS NO CURRENT PLANS TO PERFORM A REVISION SURGERY, UNLESS THE SCREW CONTINUES TO BACK OUT. HE WILL CONTINUE MONITORING THE PATIENT. IF THERE ARE UPDATES A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698071 ARANAX ANTERIOR CERVICAL PLATING SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ X-SPINE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other