BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE

    MDR report key: 4297391 · Received November 11, 2014

    Report

    Report Number
    3004893332-2014-00003
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 30, 2014
    Report Date
    November 11, 2014
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K101848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DURING A FOLLOW UP APPOINTMENT, IT WAS NOTED THAT A SCREW BACKED OUT OF A CERVICAL PLATE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728015 SAPPHIRE CERVICAL SCREW KWQ SPINAL ELEMENTS, INC. 2X240-0XX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization