BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 24956267 · Received April 22, 2026

    Report

    Report Number
    1723170-2026-00639
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    February 24, 2026
    Report Date
    April 22, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000198626
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 733457, SERIAL/LOT #: (B)(6): H3, H6; A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE PROBE WAS REPLACED AND THE SYSTEM THEN PASSED TESTING. CODES B01, C13, AND D02 ARE APPLICABLE TO THIS ANALYSIS. THE PROBE, LOT NUMBER: 191107, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. AS REPORTED, THE TIP OF THE RETURNED PROBE WAS SLIGHTLY BENT. OTHERWISE, WITH MARKERS ATTACHED AND FULLY SEATED, THE PROBE DISPLAYED GOOD GEOMETRY AND DIVOT ERROR READINGS WITH NORMAL TRACKING AND VERIFICATION. CODES B01, C13, AND D02 ARE APPLICABLE TO THIS 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEFORMATION OF THE SERVICE PROBE TIP. THE OPERATION WAS COMPLETED USING A DIFFERENT INSTRUMENT. THE DEVICE WILL BE REPLACED WITH A NEW ONE IN THE FUTURE. SYSTEM CHECK-OUT IS NOT NECESSARY BECAUSE IT IS AN INSTRUMENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446493 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000198626

    Patients

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