BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATOMIC ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1313167 · Received February 13, 2009

    Report

    Report Number
    3004893332-2009-00001
    Event Type
    Injury
    Date Received
    February 13, 2009
    Date of Event
    January 19, 2008
    Report Date
    January 26, 2009
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K060491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS WAS A CASE OF PSEUDOARTHROSIS. SPINAL ELEMENTS' ANTERIOR CERVICAL PLATE AND SCREWS WERE REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER MANUFACTURER'S SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATOMIC ANTERIOR CERVICAL PLATE SYSTEM KWQ SPINAL ELEMENTS, INC. 25002-035

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention MODEL# 25240-014