BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2150812 · Received June 21, 2011

    Report

    Report Number
    1723170-2011-01120
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 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

    NO PT INFORMATION AS NO PT WAS PRESENT IN THIS CONCERN. MEDTRONIC REP HAD A LOANER VERTEK ARM THE SITE BORROWED UNTIL THEY ORDERED A NEW ONE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE HAD A VERTEK ARM THAT WOULD NOT TIGHTEN. THIS WAS NOT DISCOVERED DURING SURGERY ADN DID NOT IMPACT CASE COVERAGE.

    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