BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 24526529 · Received March 5, 2026

    Report

    Report Number
    1723170-2026-00360
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 28, 2026
    Report Date
    May 21, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000359881
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 735737, VERSION: 2.1.0. H3, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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

    H2 ADDITIONAL INFORMATION: UPDATED SECTION A. H3,H6: THE 9735821R CAMERA, LOT NUMBER: P920124, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FAULT WAS FOUND. THE RETURNED POSITION S ENSOR UNIT (PSU) HAD SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG DID NOT SHOW ANY ADVERSE EVENTS. THE PSU PASSED AN ACCURACY TEST (AAK) AT .170MM WITH A PASSING THRESHOLD OF .250MM. THE ANALYST WAS NOT ABLE TO REPLICATE THE REPORTED FAILURE. CODES B01, C08, C13, C19, AND D02 ARE APPLICABLE. 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

    H2 ADDITIONAL INFORMATION: UPDATED B5, D10 AND ADDITIONAL CODES. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735764 COMPUTER, SERIAL LOT/SW VERSION: - PRODUCT ID: 9736411 SOLID STATE DRIVE, SERIAL LOT/SW VERSION: - PRODUCT ID: 9735821 CAMERA, SERIAL LOT/SW VERSION: - H3, H6: THE SYSTEM WAS SERVICED IN THE FIELD BY A MEDTRONIC REPRESENTATIVE. THERE WAS AN OPTICAL COMMUNICATION FAILURE. THERE WERE ISSUES WITH THE SYSTEM LAGGING/VERIFICATION OF INSTRUMENTS AS WELL AS THE CAMERA WAS NOT PICKING UP INSTRUMENTS WHEN REGISTERED. THE INSTRUMENTS WERE NOT BENT OR MISHANDLED AND NO LINE OF SIGHT ISSUES WERE OBSERVED. THE COMPUTER, SOLID STATE DRIVE (SSD), AND CAMERA WERE REPLACED. CODES B01, C08, C13, AND D02 ARE APPLICABLE. IMG CODE G0200701 APPLIES TO THE COMPUTER, G0200702 APPLIES TO THE SOLID STATE DRIVE, AND G05001 APPLIES TO THE CAMERA. 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 IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SURGEON EXPERIENCED DIFFICULTY REGISTERING THE PATIENT. SPECIFICALLY THE INSTRUMENTS USED TO REGISTER WOULD INTERMITTENTLY TRACK. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS A POSTERIOR SPINAL FUSION. THIS ISSUE CAUSED A 15 MINUTE SURGICAL DELAY. THE INSTRUMENTS THAT WERE NOT TRACKING WERE ALL OF THE TRACKERS INTERMITTENTLY AND THE CHICKEN FOOT. TROUBLESHOOTING WAS PERFORMED DURING THE CASE. THE CAMERA WAS SHIFTED, THE BALLS WERE REPLACED, AND A NEW TRACKER SET WAS USED. THE COMPUTER, SOLID STATE DRIVE (SSD), AND THE CAMERA WERE REPLACED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207076 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000359881

    Patients

    Seq Age Sex Outcome Treatment
    1