BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRESS SPINAL IMPLANT SYSTEM

    MDR report key: 5908341 · Received August 26, 2016

    Report

    Report Number
    3005031160-2016-00073
    Event Type
    Malfunction
    Date Received
    August 26, 2016
    Date of Event
    July 28, 2016
    Report Date
    July 28, 2016
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    MNH
    PMA / PMN Number
    K120832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT MENTIONS INSTRUMENTS WITH ALLEGED BIO-CONTAMINATION FOUND BY A DISTRIBUTOR UPON RECEIPT OF THE TRAY. UPON VISUAL EXAMINATION OF THE RETURNED 5.5MM TAP AND TRAY, THERE WERE NO BIO-CONTAMINATES FOUND. ALTHOUGH THE INSTRUMENTS WERE EXAMINED AND THE COMPLAINT WAS NOT CONFIRMED, THE INCIDENT COULD POTENTIALLY CAUSE A SERIOUS INJURY OR DEATH IF THE INCIDENT WERE TO REOCCUR.

    Description of Event or Problem · 1

    DISTRIBUTOR CALLED IN TO REPORT THAT TRAY H23 WAS FOUND DURING THEIR INTERNAL INSPECTION TO HAVE MATTER STUCK WITHIN THE CANNULATION OF THE 5.5MM TAP THAT COULD NOT BE REMOVED. ALSO REPORTED THAT THE TRAY ITSELF WAS DIRTY AND THERE WERE OTHER INSTRUMENTS DIRTY WITHIN THE TRAY AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559414 XPRESS SPINAL IMPLANT SYSTEM SPINAL FUSION IMPLANT SYSTEM MNH X-SPINE SYSTEMS, INC. X010-0151 3344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other