BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3180886 · Received June 20, 2013

    Report

    Report Number
    1723170-2013-00457
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP BY MEDTRONIC REPRESENTATIVE REPORTS THE PATIENT WAS IN GOOD CONDITION WHEN DISCHARGED FROM THE HOSPITAL. AFTER THE SURGERY, THEY USED A SAWBONE, IMAGED IT AND NAVIGATED. ACCURACY WAS CHECKED AND THE SYSTEMS (O-ARM AND S7) WERE WORKING GOOD. THEY DETERMINED THE ISSUE WAS RELATED TO THE SCREWS NOT ATTACHING COMPLETELY TO THE DRIVER. SOFTWARE INVESTIGATION NOT BEEN COMPLETED AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE NAVIGATION SYSTEM WAS TESTED AND FOUND TO BE FULLY FUNCTIONAL. THE SUSPECT DRIVER WAS REPLACED AND THERE HAVE BEEN NO SUBSEQUENT REPORTED ISSUES. UPON COMPLETION OF THE SOFTWARE INVESTIGATION, NO SOFTWARE FAULTS OR ANOMALIES WERE FOUND TO BE THE CAUSE OF THE ALLEGED INACCURACY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, SCREW FIXATION L5-L4, THE SURGEON ALLEGED AN APPROXIMATE 2MM-4MM INACCURACY. THE SURGEONS NAVIGATED ALL 4 SCREWS AND 3D SPIN WAS ACQUIRED IN ORDER TO VERIFY THE FINAL POSITION OF THE SCREWS. IN THE IMAGES ALL THE SCREWS WERE OUT OF PLACE. THE SURGEONS REMOVED ALL THE SCREWS AND REPLACED THEM. IT WAS NOTED THE SURGEONS DO NOT BELIEVE THE REFERENCE FRAME MOVED DURING THE CASE. THEY CHECKED THE SCREWDRIVER WITH DIFFERENT SCREWS AND DETERMINED THAT THEY WERE NOT TIGHTENING TO THE SCREWDRIVER. THE SURGEON DID NOT USE ANY TAPS DURING THE SURGERY. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE NAVIGATION SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL EVENT DESCRIPTION: A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SUSPECT DRIVER USED DURING THE REPORTED EVENT DID NOT BELOW TO MEDTRONIC NAVIGATION, INC. HOWEVER, IT WAS NAVIGATED. THEY ATTACHED A TERA TRACKER TO THE SCREWDRIVER. THIS SCREWDRIVER WAS COMPATIBLE WITH NAVIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279786 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention