BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2033613 · Received February 11, 2011

    Report

    Report Number
    1723170-2011-00109
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC INC REP WAS PRESENT DURING CASE AND CONFIRMED THE STRIPPED SCREW AND THAT THE CASE FINISHED SUCCESSFULLY AFTER REMOVAL OF THE SCREW. WHILE THERE WAS NO PT HARM ALLEGED, THIS CASE IS BEING REPORTED BECAUSE OF THE POTENTIAL OF A STRIPPED SCREW NOT BEING REMOVED EASILY, WHICH COULD RESULT IN ADDITIONAL MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED THAT THE SCREW FOR THE EXTERNAL NAVIGUS BASE STRIPPED AS THEY WERE TRYING TO REMOVE IT AFTER THE PROCEDURE. THEY WERE ABLE TO PRY THE BASE OFF WITH NO NEGATIVE IMPACT TO THE PT. AFTER REMOVING THE BASE, THE SURGEON WAS ABLE TO PROCEED AND CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR