BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2893679 · Received January 2, 2013

    Report

    Report Number
    1723170-2012-00711
    Event Type
    Other
    Date Received
    January 2, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S WEIGHT IS NOT AVAILABLE FROM THE SITE. THE SYSTEM'S FILES HAVE NOT YET BEEN REC'D BY THE MANUFACTURER FOR INVESTIGATION. SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINE PROCEDURE, THE O-ARM EXAMS WERE INITIALLY ACCURATE. APPROXIMATELY 45 MINUTES INTO THE THORACIS PROCEDURE, THE SURGEON ALLEGED THE INSTRUMENTS WERE TOO SUPERIOR AND NOT ACCURATE; THE POINT TIP WAS ABOUT 5-10MM ABOVE THE BONE THE SURGEON WAS TOUCHING. THE SURGEON ACCURATELY TAPPED THE PEDICLES; THEN NOTED HE WAS INACCURATE WHEN READY FOR SCREWS. THERE WAS NO NEED TO NAVIGATE AND THE SCREWS WERE PLACED IN TAPPED PEDICLES. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female