BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER NAV3I(TM) PLATFORM

    MDR report key: 4213311 · Received October 30, 2014

    Report

    Report Number
    0001811755-2014-03842
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K993239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE REPORTED EVENT COULD BE DUPLICATED, AND INCORRECT SURFACE REGISTRATION WAS DETERMINED TO BE A POSSIBLE ROOT CAUSE.

    Description of Event or Problem · 1

    DURING A CRANIOTOMY FOR TUMOR PARIETAL RESECTION WITH LANGUAGE AND MOTOR MAPPING USING STRYKER NAV3I AND CRANIAL MAP SOFTWARE, THE SURGEON NOTICED AN INACCURACY OF THE SYSTEM. AFTER OPENING THE BONE FLAP TO ACCESS THE TUMOR LOCATION, THE SURGEON REPORTED NAVIGATION TO BE OFF APPROXIMATELY 2CM, BASED ON THE MRI. MASK REGISTRATION WITH RESCUE POINTS WERE USED ALONG WITH A LANDMARK CHECK FOR REGISTRATION. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO CLINICALLY SIGNIFICANT DELAY WERE REPORTED WITH THIS EVENT. NAVIGATION WAS CANCELED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ULTRASOUND.

    Description of Event or Problem · 1

    DURING A CRANIOTOMY FOR TUMOR PARIETAL RESECTION WITH LANGUAGE AND MOTOR MAPPING USING STRYKER NAV3I AND CRANIAL MAP SOFTWARE, THE SURGEON NOTICED AN INACCURACY OF THE SYSTEM. AFTER OPENING THE BONE FLAP TO ACCESS THE TUMOR LOCATION, THE SURGEON REPORTED NAVIGATION TO BE OFF APPROXIMATELY 2CM, BASED ON THE MRI. MASK REGISTRATION WITH RESCUE POINTS WERE USED ALONG WITH A LANDMARK CHECK FOR REGISTRATION. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO CLINICALLY SIGNIFICANT DELAY WERE REPORTED WITH THIS EVENT. NAVIGATION WAS CANCELED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ULTRASOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697542 STRYKER NAV3I(TM) PLATFORM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1