BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 23708536 · Received December 3, 2025

    Report

    Report Number
    1723170-2025-03862
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    November 5, 2025
    Report Date
    February 27, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000198626
    PMA / PMN Number
    K162309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: NO PARTS WERE RECEIVED BY THE MANUFACTURER FOR EVALUATION. CODES B17, C20, AND D15 ARE APPLICABLE. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735736, SOFTWARE VERSION: 2.1.0 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3, H6: A SOFTWARE ANALYSIS WAS INITIATED. THE LOGS AND ARCHIVE WERE REVIEWED. ON THE REPORTED EVENT DATE, 7 SESSIONS WERE OBSERVED UNDER SPINALFUSION, CT SPINE. OF THESE, SESSIONS 3 AND 4 SHOWED MULTIPLE SUCCESSFUL REGISTRATIONS WITH TYPICAL TASK TRANSITIONS SELECT PROCEDURE, IMAGES, PLAN, INSTRUMENTS, REGISTRATION AND REASONABLE ERROR METRICS, APPROXIMATELY 2.3¿4.4 MM WITH 7¿8 TOUCH/IMAGE POINTS, AND ONE 0.95 MM ENTRY WITH 4/4 POINTS. FROM THE ARCHIVE, SIX COMPUTER TOMOGRAPHY (CT) EXAMS WERE PRESENT, CT-1 WITH 265 SLICES; CT-2 AND CT-3 WITH 330 SLICES; AND CT-4, CT-5, AND CT-6 WITH 216 SLICES. ALL EXAMS HAD 1 MM SPACING/THICKNESS AND NO SAVED REGISTRATIONS. LOADING THE PROVIDED DATASETS IN-HOUSE, CT-1, CT-2, CT-3, AND CT-6 FAILED TO DISPLAY THE 3D MODEL AT REGISTRATION, AND THE EDITMODEL FUNCTION WAS UNRESPONSIVE, CONSISTENT WITH THE USER¿S REPORT. CT-4 AND CT-5 ALLOWED EDITMODEL AND THRESHOLD ADJUSTMENT, RESULTING IN WORKABLE MODELS. THIS BEHAVIOR CORRESPONDED WITH THE LOGGED MODEL-BUILDING ERRORS INDICATING ¿MODEL VOLUME LESS THAN MINIMUM¿ AND ¿CANNOT TRANSITION TO MODEL BUILDING TASK TO EDIT MODEL.¿ BASED ON THE ABOVE FINDINGS, THE ANALYST WAS ABLE TO REPRODUCE THE ISSUE IN-HOUSE USING THE PROVIDED ARCHIVE. THIS ISSUE WAS CONSISTENT WITH A KNOWN SOFTWARE ISSUE. CODES B01, C10, AND D02 ARE APPLICABLE TO THE SOFTWARE ANALYSIS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE WEEK BEFORE THE SURGERY, THE PHYSICIAN HAD LOADED COMPUTED TOMOGRAPHY (CT) DATA INTO THE NAVIGATION SYSTEM AND USED DATA FOR WHICH A REGISTRATION PLAN HAD BEEN CREATED. DURING REGISTRATION, 8 POINTS WERE TAKEN BY TOUCH AND AN ACCURACY OF 2.2 MM WAS DISPLAYED; HOWEVER, WHEN PROCEEDING TO SURFACE REGISTRATION, THE NUMBER OF POINTS BECAME 0 AND THE 3D DISPLAY COULD NOT BE SHOWN. WHEN THE EDIT MODEL BUTTON WAS PRESSED, THE SCREEN DID NOT CHANGE, AND COPIES CONTINUED TO BE CREATED UNDER PREVIOUS REGISTRATION. EVEN AFTER RELOADING THE DATA FROM THE COMPACT DISC (CD), THE SAME SYMPTOMS OCCURRED AND REGISTRATION COULD NOT BE COMPLETED DURING SURFACE REGISTRATION. THE FIELD-OF-VIEW (FOV) WAS 179.71. BECAUSE NAVIGATION COULD NOT BE USED, THE PHYSICIAN DECIDED TO CANCEL THE SURGERY POST-INC ISION. THE PROCEDURE WAS TERMINATED AND THE SURGICAL SITE WAS CLOSED. THERE WAS NO SURGICAL DELAY, BUT THE SURGERY WAS POSTPONED FOR ANOTHER DAY. THIS RESULTED IN AN EXTENDED HOSPITAL STAY. NO SURGICAL INFECTIONS OR OTHER COMPLICATIONS WERE NOTED. AFTER THE SURGERY, CT DATA WAS OBTAINED ON CD, AND DATA WITH THE FOV NARROWED TO 160 WAS LOADED, BUT THE SAME SITUATION PERSISTED AND EDIT MODEL COULD NOT BE PERFORMED. THE 3D MODEL COULD NOT BE EDITED, AND IT WAS NOT POSSIBLE TO PROCEED TO SURFACE REGISTRATION. LATER, VARIOUS IMAGES WERE EXAMINED. ON THE NAVIGATION SYSTEM, DATA LABELED CT-4 AND CT-5 WERE ABLE TO BE EDITED IN THE MODEL AND REFLECTED IN THE 3D VIEW. THERE WERE ALSO DATA THAT COULD NOT PROCEED TO EDITMODEL. IT HAS BEEN CONFIRMED THAT ITEMS SUCH AS FOV WERE IN ACCORDANCE WITH THE PROTOCOL. SUBSEQUENTLY, IMAGE VERIFICATION WAS PERFORMED AGAIN. SOME CT SCANS ON THE CD COULD PROCEED TO THE EDIT MODEL STEP, WHILE OTHERS COULD NOT, SO AN ISSUE WAS SUSPECTED IN THE CD CREATION PROCESS. WHEN IMAGES WERE DOWNLOADED FROM THE NETWORK TO THE PLANNING STATION AND DATA OBTAINED VIA THE PLANNING STATION, THE RESULTS WERE THE SAME AS WITH THE CD. ONLY THE DATA THAT COULD ADVANCE TO THE EDIT MODEL STEP ON THE CD COULD ALSO BE READ CORRECTLY WHEN OBTAINED VIA THE NETWORK.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT NAVIGATION COULD NOT BE USED, SO THE SURGICAL SITE WAS CLOSED THAT DAY. THIS RESULTED IN A REOPERATION AND AN EXTENDED HOSPITAL STAY. DURING THIS PERIOD, THERE WAS NO INFORMATION REGARDING SURGICAL SITE INFECTION OR OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2850050 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000198626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R "SEE H11...."