BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNUM+

    MDR report key: 1591093 · Received January 26, 2010

    Report

    Report Number
    3004893332-2010-00002
    Event Type
    Injury
    Date Received
    January 26, 2010
    Date of Event
    January 4, 2010
    Report Date
    January 25, 2010
    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

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: "NO DEVICE FAILURE". DR. (B) (6) STATED THAT THERE IS NOTHING WRONG WITH THE DEVICE. "USER INTERFACE CONTRIBUTED TO THE EVENT". THE INSTRUMENT SLIPPED FROM THE PHYSICIAN'S HAND. THE COMPLAINANT REPORTED THAT A TOOL SIMPLY SLIPPED AND CAUSED THE SCENARIO, AND THE SPINAL ELEMENTS' DEVICES DID NOT FAIL TO PERFORM IN ANY WAY.

    Description of Event or Problem · 1

    THIS WAS A CASE OF HUMAN ERROR. DURING THE IMPLANTATION OF THE MAGNUM+ IMPLANT ON (B) (6) 2010, THE SURGEON SLIPPED WITH AN INSTRUMENT AND CAUSED A VASCULAR TEAR. ASSISTING VASCULAR SURGEON REPAIRED VASCULAR TEAR. IMPLANTATION WAS COMPLETED WITH NO FURTHER INCIDENCES. THE PT 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. 14055-025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention