BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV CD HORIZON® SOLERA¿ MAST 4.75 DRIVER

    MDR report key: 3011501 · Received March 19, 2013

    Report

    Report Number
    1723170-2013-00198
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE AT TIME OF THIS REPORT, HOWEVER, HAS BEEN REQUESTED. SUSPECT DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINE PROCEDURE, THE SURGEON BROKE THE TIP OFF THEIR SOLERA SCREWDRIVER WHILE TIGHTENING A SCREW. THE TIP WAS RETRIEVED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114362 NAV CD HORIZON® SOLERA¿ MAST 4.75 DRIVER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120430

    Patients

    Seq Age Sex Outcome Treatment
    1