BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNUM+

    MDR report key: 1546850 · Received November 25, 2009

    Report

    Report Number
    3004893332-2009-00013
    Event Type
    Injury
    Date Received
    November 25, 2009
    Date of Event
    November 19, 2009
    Report Date
    November 19, 2009
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    MAX
    PMA / PMN Number
    K083475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RADIOGRAPHIC EVALUATION REVEALED THAT THE VERTEBRAL BODY SUPERIOR TO THE MAGNUM+ IMPLANT HAD FRACTURED, CAUSING THE IMPLANT TO MIGRATE SLIGHTLY ANTERIORLY. A REVISION SURGERY WAS PERFORMED IN 2009 TO REMOVE IMPLANTS AND RE-STABILIZE. 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 MAGNUM+ MAX, MQP MAX SPINAL ELEMENTS, INC. 14025-614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention