BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER CERVICAL PLATES

    MDR report key: 5035595 · Received August 21, 2015

    Report

    Report Number
    MW5055771
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    X-SPINE SYSTEMS INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    THE IMPLANT, WHICH IS A PLATE FROM X-SPINE WAS IMPLANTED IN THE PATIENT BUT THE SCREW WENT STRAIGHT THROUGH THE HOLE OF THE PLATE. THE PLATE WAS EXPLANTED AND ANOTHER PLATE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554822 SPIDER CERVICAL PLATES SPIDER CERVICAL PLATES KWQ X-SPINE SYSTEMS INC. N600000109

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR