BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 24415759 · Received February 23, 2026

    Report

    Report Number
    1723170-2026-00293
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 13, 2026
    Report Date
    February 23, 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). PRODUCT ID: 9733886, SERIAL/LOT #: (B)(6). H3, H6; THE PROBE, LOT NUMBER: P191107, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED PROBE HAD A GOOD GEOMETRY / HIGH DIVOT ERROR. CODES B01, C13, AND D02 ARE APPLICABLE TO THIS ANALYSIS. THE REFERENCE FRAME, LOT NUMBER: 230606, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. IT WAS DETERMINED THAT THERE WAS NO FAULT FO UND. CODES B01, C19, AND D14 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 CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE CERVICAL PROBE WAS BENT AND THE REFERENCE FRAME WOULD NOT VERIFY. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47149 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000198626

    Patients

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