BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1753511 · Received July 9, 2010

    Report

    Report Number
    1723170-2010-00036
    Event Type
    Other
    Date Received
    July 9, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 18, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT ID WAS NOT AVAILABLE BUT HAS BEEN REQUESTED. PT WEIGHT WAS NOT AVAILABLE BUT HAS BEEN REQUESTED. MEDTRONIC NAVIGATION'S STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM WAS USED TO CREATE AN OPENING FOR THE PEDICLE SCREW PLACEMENT. NAVIGATION WAS NOT USED FOR SCREW PLACEMENT.

    Description of Event or Problem · 1

    DURING SPINE SURGERY (T1-T3 FUSION) WITH THE STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM THE SURGEON NAVIGATED TO CREATE AN OPENING FOR PEDICLE SCREWS. THE SURGEON PLACED 3 SCREWS ON THE LEFT SIDE FROM T3 TO T1 BEFORE MOVING TO THE RIGHT SIDE TO PLACE THREE SCREWS FROM T3 TO T1. THE OPERATING ROOM STAFF STIMULATED THE 2ND AND 6TH SCREWS ONLY THEY NOTICED THAT THEY WERE RECEIVING A BAD SIGNAL WHEN THEY STIMULATED THE LAST SCREW. A POST OPERATIVE IMAGE WITH THE O-ARM SYSTEM WAS ACQUIRED AND THE SURGEON NOTICED THAT THE LEFT T1 SCREW WAS POSITIONED MEDIALLY. ALL OF THE OTHER SCREWS WERE PLACED CORRECTLY. SURGEON REMOVED THE SCREW AND THE PT WAS SENT FOR A POST OPERATIVE CT. A FOLLOW-UP REPORT FROM THE SURGEON INDICATES THERE IS SOME SIGNAL CHANGE IN THE CORD CONSISTENT WITH EDEMA OR STROKE. PT'S CANAL WAS EXTREMELY TIGHT PRE-OPERATIVELY. PT IS IMPROVING ON STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC SYSTEM (HAW) HAW MEDTRONIC NAVIGATION TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention O-ARM SYSTEM