BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATOMIC ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1226550 · Received November 11, 2008

    Report

    Report Number
    3004893332-2008-00014
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 11, 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

    THE ATTENDING PHYSICIAN OBSERVED ONE SCREW BACKING OUT FROM AN ANTERIOR CERVICAL PLATE ON FILMS TAKEN DURING A FOLLOW-UP EXAM. THE ATTENDING SURGEON PERFORMED A POSTERIOR CERVICAL FUSION IN 2008 TO FURTHER STABILIZE THE ANATOMY. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention