BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2980887 · Received February 27, 2013

    Report

    Report Number
    1723170-2013-00133
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER NOT AVAILABLE FROM THE SITE, HOWEVER, HAS BEEN REQUESTED. SOFTWARE INVESTIGATION COMPLETED, FINDING THAT AS REPORTED, THE REFERENCE FRAME HAD BEEN BUMPED WHICH MADE THE REGISTRATION INVALID. THE SOFTWARE IS FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINE PROCEDURE, THE SURGEON NOTED BEING APPROXIMATELY 60 DEGREES OFF IN THE CORONAL PLANE. DURING THE FIRST HALF OF THE SURGERY EVERYTHING WAS ACCURATE; THE INACCURACY OCCURRED IN THE SECOND HALF. THE SURGEON WAS USING THE PASSIVE PLANAR PROBE TO LINE UP TRAJECTORY FOR THE SCREWS, HE WAS NOT NAVIGATING THE SCREWS. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. AFTER THE EVENT, IT WAS REPORTED THAT THE REFERENCE FRAME HAD BEEN BUMPED, LEAVING IT TO ANGLE FURTHER DOWNWARD. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85521 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR