BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4157469 · Received October 9, 2014

    Report

    Report Number
    1723170-2014-01075
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    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 AGE NOT AVAILABLE FROM THE SITE. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE, FOLLOWING UP WITH THE SITE, REPORTED THAT THE SITE HAS HAD SEVERAL CASES SINCE THIS ISSUE AND THE BEHAVIOR HAS NOT RECURRED. A MEDTRONIC REPRESENTATIVE TESTED THE SYSTEM AND WAS UNABLE TO RECREATE THE REPORTED ISSUE; THE MEDTRONIC REPRESENTATIVE ALSO PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE, THE SURGEON ALLEGED THE NAVIGATION SYSTEM WAS INACCURATE. THE SURGEON STATED THE FIRST TWO LEVELS WERE ACCURATE BUT THE LAST TWO LEVELS WERE INACCURATE BY APPROXIMATELY 4-6 MILLIMETERS TO THE RIGHT. NO SPINE HARDWARE NEEDED TO BE RE-POSITIONED DUE TO THE ALLEGED INACCURACY. THE SURGEON NOTICED THE INACCURACY PRIOR TO PLACING HARDWARE ON THE LAST TWO LEVELS. THE SURGEON OPTED TO TAKING AN ADDITIONAL O-ARM SPIN FOR THOSE PARTICULAR LEVELS TO REGAIN THE ACCURACY. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635192 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1