BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081180 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00858
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO UPDATE AS TO IF SITE IS ORDERING A NEW VERTEK ARM. DEVICE NOT RETURNED, NO EVAL WILL BE COMPLETED.

    Description of Event or Problem · 1

    SITE STATED THAT THE VERTEK ARM IS IN THE UNLOCKED POSITION AND WILL NOT TIGHTEN. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    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