BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER NAV3(TM) PLATFORM

    MDR report key: 3132492 · Received May 29, 2013

    Report

    Report Number
    0001811755-2013-01207
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K993239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED, IF ADDITIONAL INFORMATION IS OBTAINED AND REQUIRES REPORTING. (B)(4): THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT WITHOUT AN EVALUATION OF THE DEVICE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN FESS PROCEDURE AT THE USER FACILITY, THE MASK WAS REGISTERED WITH THE SCREEN SHOWING A MEAN DEVIATION OF 0.9MM, BUT AN INACCURACY OF SEVERAL CENTIMETERS WAS NOTICED VISUALLY WHEN THE TOUCH OFF WITH THE POINTER WAS DONE. IT WAS REPORTED THAT IS UNKNOWN IF THE POINTER WAS BENT AFTER REGISTRATION. THE USER DISPOSED OF THE MASK IN USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE USE OF TRADITIONAL METHODS, INSTEAD OF WITH THE USE OF BACKUP. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN FESS PROCEDURE AT THE USER FACILITY, THE MASK WAS REGISTERED WITH THE SCREEN SHOWING A MEAN DEVIATION OF 0.9MM, BUT AN INACCURACY OF SEVERAL CENTIMETERS WAS NOTICED VISUALLY WHEN THE TOUCH OFF WITH THE POINTER WAS DONE. IT WAS REPORTED THAT IS UNKNOWN IF THE POINTER WAS BENT AFTER REGISTRATION. THE USER DISPOSED OF THE MASK IN USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE USE OF TRADITIONAL METHODS, INSTEAD OF WITH THE USE OF BACKUP. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235950 STRYKER NAV3(TM) PLATFORM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1