BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATOMIC

    MDR report key: 4307216 · Received November 25, 2014

    Report

    Report Number
    3004893332-2014-00004
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Date of Event
    November 24, 2014
    Report Date
    November 25, 2014
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K060491
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY TO REMOVE SCREWS BACKING OUT AT C7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766712 ATOMIC CERVICAL SCREW KWQ SPINAL ELEMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention