BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAV CD HORIZON SOLERA 4.75MM DRIVER

    MDR report key: 2243951 · Received September 6, 2011

    Report

    Report Number
    MW5022148
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    July 20, 2011
    Report Date
    September 6, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LUMBAR POSTERIOR LATERAL FUSION, L5-S1 FOR SPONDYLOLISTHESIS THE TIP OF THE SCREWDRIVER SNAPPED AND LODGED INTO THE SCREW HEAD. IT WAS NOT NECESSARY TO REMOVE THE TIP OF THE SCREW DRIVER BECAUSE THE SCREW WAS IN GOOD PLACEMENT. HEMOSTASIS WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC NAV CD HORIZON SOLERA 4.75MM DRIVER SCREWDRIVER HXX MEDTRONIC 9734279 100902

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention