BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATOMIC CERVICAL PLATE SYSTEM

    MDR report key: 2581248 · Received August 30, 2010

    Report

    Report Number
    3004893332-2010-00004
    Event Type
    Other
    Date Received
    August 30, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 9, 2010
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K060491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DEVICE SCREWS LOOSENED. SCREWS NEVER SEEMED TO LOCK, JUST SPUN, NEVER CAPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATOMIC CERVICAL PLATE SYSTEM ATOMIC CERVICAL PLATE SYSTEM KWQ SPINAL ELEMENTS, INC. 25002-029 010871

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention