BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 21285423 · Received January 31, 2025

    Report

    Report Number
    1723170-2025-00408
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 9, 2025
    Report Date
    October 10, 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

    CONTINUATION OF D10: PRODUCT ID 9735670 (SERIAL: (B)(6)); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 9731567 (LOT: 347853); PRODUCT TYPE: 2543-MNAV - SYSTEM; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 961579 (LOT: 221229); PRODUCT TYPE: 2543-MNAV - SYSTEM; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 961581 (070222); 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 9735740 STEALTH S8 SPINE 2.1.0 H3) NO PARTS HAVE BEEN RETURNED FOR 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

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID:9735821, LOT NUMBER: - 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) A SOFTWARE ANALYSIS WAS INITIATED. IT WAS DETERMINED THERE WAS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE EVENT. 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 DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE, THE SURETRAK APPEARED INACCURATE IN THE SOFTWARE BY 1MM MEDIAL. THE SURGEON REMOVED THE SURETRAK FROM THE DRILL GUIDE AND USED A HAND-POWERED AWL TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, TESTING OF THE SURETRAK WAS CONDUCTED, AND THE ISSUE WAS REPLICATED. THE BLACK SURETRAK HAD A GEOMETRY ERROR OF 0.45, ONE OF ITS SPHERES WAS NOT VISIBLE, AND IT WAS UNABLE TO NAVIGATE CONSISTENTLY. TESTING WITH A SECOND SET OF SURETRAKS DID NOT REPLICATE THE ISSUE.  THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND NO REPORTED DELAY. THE COMPLAINT REGARDING THE ACCURACY ISSUE WAS MADE AGAINST ALL THREE NAVLOCKS. HOWEVER, WHEN PERFORMING A SYSTEM CHECKOUT, ONLY THE BLACK NAVLOCK SHOWED PHYSICAL EVIDENCE WHERE ONE OF THE SPHERE WAS NOT TRACKABLE BY THE CAMERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519761 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male SEE H11...| SEE H11...