BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATOMIC ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1517134 · Received October 27, 2009

    Report

    Report Number
    3004893332-2009-00011
    Event Type
    Injury
    Date Received
    October 27, 2009
    Date of Event
    October 20, 2009
    Report Date
    October 21, 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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE ATTENDING PHYSICIAN OBSERVED A PROMINENT SCREW FROM AN ANTERIOR CERVICAL PLATE CONSTRUCT THAT WAS IMPLANTED IN 2008. AN ADJACENT LEVEL PROCEDURE WAS PERFORMED IN 2009. THE CONSTRUCT WITH A PROMINENT SCREW WAS REMOVED DURING THE ADJACENT LEVEL PROCEDURE. THE CASE WAS COMPLETED WITH NO FURTHER INCIDENCES. THE PATIENT IS REPORTED TO BE IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATOMIC ANTERIOR CERVICAL PLATE SYSTEM KWQ SPINAL ELEMENTS, INC. 25145-014 070322

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention