BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATOMIC ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1261459 · Received December 10, 2008

    Report

    Report Number
    3004893332-2008-00015
    Event Type
    Injury
    Date Received
    December 10, 2008
    Date of Event
    November 22, 2008
    Report Date
    December 1, 2008
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K060491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CERVICAL PLATE SCREW WAS OBSERVED TO HAVE MOVED INTO THE INFERIOR DISC SPACE OCCUPIED BY A CAGE ONE DAY POST-OPERATIVELY. A REVISION SURGERY WAS PERFORMED TO REPLACE THE PLATE AND SCREWS. IT WAS REPORTED BY HEALTH CARE PROFESSIONALS THAT THIS EVENT OCCURRED BECAUSE THE PATIENT IS OBESE AND THAT SPINAL ELEMENTS' DEVICES DID NOT FAIL TO PERFORM IN ANY WAY. THE REVISION CASE WAS COMPLETED WITH NO FURTHER INCIDENCES. THE PATIENT IS REPORTED TO BE IN GOOD HEALTH, AND WILL CONTINUE TO BE MONITORED CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATOMIC ANTERIOR CERVICAL PLATE SYSTEM KWQ SPINAL ELEMENTS, INC. 25240-012

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention