BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 3041546 · Received April 8, 2013

    Report

    Report Number
    1723170-2013-00261
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE. THE SYSTEM HAS BEEN PERFORMING PROPERLY DURING SUBSEQUENT USE.

    Additional Manufacturer Narrative · 1

    THE PATIENT WEIGHT WAS NOT PROVIDED BY THE SITE. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    A MEDTRONIC (B)(4) REPRESENTATIVE REPORTED AN INACCURACY DURING A SPINE PROCEDURE USING FLUORO MERGE. THEY USED FLUOROMERGE SOFTWARE FOR THE POSTERIOR SPINAL FUSION WITH A SPINAL CANAL STENOSIS PATIENT WHERE THEY WERE PLACING THE PEDICLE SCREWS ON LEVELS L5/S AND L2/3. FLUOROMERGE SOFTWARE WAS WORKING OK FOR L5/S. THEY THEN ATTACHED THE REFERENCE FRAME TO L3 SPINOUS PROCESS AND OBTAINED THE FRONTAL AND LATERAL IMAGES OF L2 AND L3 WITH C-ARM. THEN THEY IDENTIFIED L3 ON THE C-ARM IMAGES LOADED INTO THE NAVIGATION. THEN IDENTIFIED L3 ON THE DATA ONTO WHICH THE CT IMAGES WERE PROJECTED, AND COMPLETED FLUOROMERGE. THERE WAS NO PROBLEM WITH THE ACCURACY AND PLACED THE PEDICLE SCREWS ON L3 WITH THE USE OF NAVIGATION. WHEN PLACING THE PEDICLE SCREWS ON L2, THEY FOUND AN INACCURACY WITH THE NAVIGATION IT SHOWED L1 WHEN ACTUALLY L2 WAS BEING TOUCHED. UNDER FLUOROSCOPIC GUIDANCE, THEY FOUND THAT THE PEDICLE SCREWS HAD BEEN PLACED ON THE BOTH SIDES OF L3 AND ON THE LEFT SIDE OF L4. AT THIS POINT THEY REMOVED THE PEDICLE SCREWS FROM L4, DID FLUOROMERGE AGAIN AND PLACED THE PEDICLE SCREWS ON L2. UNDER FLUOROSCOPIC GUIDANCE THEY CONFIRMED THE PEDICLE SCREWS PLACEMENT ON L2, L3, L5 AND S1, AND THEN COMPLETED THE NAVIGATION AND CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143987 STEALTHSTATION TRIA NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TRIA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR