BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCURY SPINAL SYSTEM

    MDR report key: 1546848 · Received November 25, 2009

    Report

    Report Number
    3004893332-2009-00012
    Event Type
    Injury
    Date Received
    November 25, 2009
    Date of Event
    November 2, 2009
    Report Date
    November 3, 2009
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    MNI
    PMA / PMN Number
    K083230
    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 L5-S1 SCREWS TO BE LOOSE ON FILMS TAKEN DURING A FOLLOW-UP EXAM. A REVISION SURGERY WAS PERFORMED IN 2009 TO REMOVE THE CONSTRUCT. THE REVISION CASE WAS COMPLETED WITH NO FURTHER INCIDENCES. THE PT IS REPORTED TO BE IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCURY SPINAL SYSTEM MNI SPINAL ELEMENTS, INC. 62065-035 080535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention