BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC

    MDR report key: 1221986 · Received November 6, 2008

    Report

    Report Number
    3004893332-2008-00011
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 6, 2008
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    ODP
    PMA / PMN Number
    K071833
    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 ON FILMS TAKEN DURING A FOLLOW-UP EXAM. A REVISION SURGERY WAS PERFORMED IN 2008. THE CONSTRUCT WAS EXPLANTED, AND REPLACED WITH ANOTHER MFR'S SYSTEM. THE REVISION CASE WAS COMPLETED WITH NO FURTHER INCIDENTS. THE PT 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 MOSAIC ODP SPINAL ELEMENTS, INC. 25240-014 070784

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention