BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 21294570 · Received February 3, 2025

    Report

    Report Number
    1723170-2025-00432
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 1, 2025
    Report Date
    October 16, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. CONTINUATION OF D10: PRODUCT ID 9735670 (SERIAL: (B)(6)); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 9731567 (B)(6); PRODUCT TYPE: 2543-MNAV - SYSTEM; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 961579 (B)(6); PRODUCT TYPE: 2543-MNAV - SYSTEM; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 961581 (B)(6); PRODUCT TYPE: 2543-MNAV - SYSTEM; IMPLANT DATE N/A; EXPLANT DATE N/A SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: SW KIT (B)(6) STEALTH S8 SPINE. 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) ADDED TO SECTIONS A AND B5. 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. HOWEVER, THE SOFTWARE EVALUATION FOUND THAT A PROBABLE CAUSE WAS UNABLE TO BE DETERMINED. IT WAS REPORTED THAT THERE WAS NO ABNORMALITY CAPTURED RELATED TO THE INACCURACY OF THE INSTRUMENTS, BUT THOUSANDS OF "INFRARED INTERFERENCE ERROR" WERE OBSERVED. IT WAS SUSPECTED HARDWARE OR THE FRAME MOVEMENT MIGHT HAVE CAUSED THE REPORTED BEHAVIOR, WHICH COULD NOT BE CAPTURED IN THE LOGS. THE INFORMATION PROVIDED WAS INSUFFICIENT TO DETERMINE WHETHER A SOFTWARE ANOMALY CONTRIBUTED TO THE REPORTED BEHAVIOR. CODES B01, C19, D15 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.

    Additional Manufacturer Narrative · 0

    H2 ADDITIONAL INFORMATION: D10 AND ADDITIONAL CODES UPDATED. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821, SERIAL LOT/SW VERSION: - 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 APPEARED INACCURATE IN THE SOFTWARE BY 1MM MEDIAL DURING THE PROCEDURE. THE SURGEON TOOK THE SURETRAK OFF THE DRILL GUIDE AND USED A HAND POWERED AWL TO COMPLETE THE PROCEDURE. THE EVENT WAS REPORTED TO HAVE HAPPENED "A COUPLE OF WEEKS AGO" FROM THE NOTIFY DATE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND NO REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THAT ALL 3 INSTRUMENTS WERE INACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208262 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male SEE H11...| SEE H11....