BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2911887 · Received January 11, 2013

    Report

    Report Number
    1723170-2013-00018
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 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

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE, AT THE SITE, PERFORMED A SYSTEM ACCURACY VERIFICATION FINDING THE ACCURACY ON BOTH SIDES OF THE O-ARM PASSED WITH GOOD RESULTS; SYSTEM CONFIRMED ACCURATE. NO FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR SOFTWARE EVALUATION OF THE ROOT CAUSE OF ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN ALLEGED INACCURACY OF 1-2MM WHILE IN A POSTERIOR SPINE FUSION PROCEDURE. FROM T2-S1, THREE SCREWS WERE PLACED LATERALLY ON THE LEFT SIDE OF THE PATIENT. THE MEDTRONIC REPRESENTATIVE STATED THAT THE SCREWS WERE WITH IN 3 LEVELS OF THE FRAME. THE SURGERY WAS COMPLETED WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19113 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR