BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLECT CRANIAL NAVIGATION SOFTWARE

    MDR report key: 1894790 · Received November 5, 2010

    Report

    Report Number
    3007582679-2010-00020
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    STRYKER NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K062640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR INVESTIGATION. IF ADD'L INFO IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON IMPORTED TWO MRI IMAGE SETS. CORRELATION BETWEEN THE TWO IMAGE SETS WAS NOT POSSIBLE AND THEREFORE THE SURGEON COULD ONLY USE ONE IMAGE SET FOR SURGERY. THE PT WAS IN THE ROOM, BUT NOT AFFECTED. THERE ARE NO ALLEGATIONS OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLECT CRANIAL NAVIGATION SOFTWARE STEREOTAXIC INSTRUMENT HAW STRYKER NAVIGATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK