BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPPHIRE

    MDR report key: 4920942 · Received July 15, 2015

    Report

    Report Number
    3004893332-2015-00008
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    June 8, 2015
    Report Date
    July 15, 2015
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K101848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO SCREW BACK OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460469 SAPPHIRE SPINAL INTERVERTEBRAL BODY FIXATION KWQ SPINAL ELEMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention