BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2043275 · Received February 25, 2011

    Report

    Report Number
    1723170-2011-00165
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE REPORTED EVENT, THE MEDTRONIC REP DISCUSSED WITH THE SURGEON THE POSSIBILITY OF PT MOVEMENT AFTER THE SCAN WAS ACQUIRED. THEY WERE USING THE CRANIAL REFERENCE FRAME FOR A LOWER CERVICAL PROCEDURE. THE MEDTRONIC INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SURGERY USING THE O-ARM, NAVIGATION WAS INITIALLY ACCURATE. AS SURGERY PROGRESSED, SURGEON AGREED THAT PT MAY HAVE SETTLED ON TABLE PADDING RESULTING IN SLIGHT INACCURACIES. THE SURGEON WAS USING THE CRANIAL REFERENCE FRAME FOR A LOWER CERVICAL PROCEDURE. THE SURGERY WAS COMPLETED WITH THE USE OF THE STEALTHSTATION. THERE WAS NO NEGATIVE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR