BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4221959 · Received November 3, 2014

    Report

    Report Number
    1723170-2014-01178
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    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, FOLLOWING-UP AT THE SITE, NOTED THAT THE REFERENCE FRAME WAS BELIEVED TO HAVE BEEN BUMPED. THE INACCURACY WAS APPROXIMATELY 2-3MM. THE PATIENT'S ANGIOGRAM RESULTS CAME BACK WITH NO INJURY TO ANY VESSELS. CONTINUATION CASE WAS SCHEDULED FOR (B)(6) 2014 AND WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY AND WITHOUT ISSUE. A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A L3-S1 POSTERIOR SPINE FUSION PROCEDURE, USING SACROILIAC SCREWS, THE SURGEON ALLEGED A SCREW WAS PLACED INACCURATELY. X-RAY CONFIRMED THE LEFT SCREW WAS PLACED ACCURATELY. WHEN PLACING THE SCREWS ON THE RIGHT SIDE, THE SITE USED A UNIVERSITY OF MINNESOTA TORQUE MEASURING DEVICE ATTACHED TO THE END OF THE DRIVER. THE SURGEON MADE SEVERAL PASSES WITH THE STRAIGHT TACTILE AWL, ALSO MADE MULTIPLE PASSES WITH 8.5 AND 9.5, BOTH NAVIGATED AND NON-NAVIGATED TIPS. THESE TRAJECTORIES WERE IN CLOSE PROXIMITY AND POTENTIALLY COMPROMISED BONE QUALITY; THE TRAJECTORIES COLLAPSED IN ON EACH OTHER. WHEN THE SITE PLACED THE 9.5 X 90 SCREW, THE SCREW WENT OUT THE SCIATIC NOTCH AND REPORTEDLY MAY HAVE HIT THE GLUTEAL ARTERY. THE SURGEON OPTED TO HALT THE PROCEDURE FOR THE PATIENT TO BE GIVEN AN ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701517 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention