BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK

    MDR report key: 20077298 · Received August 27, 2024

    Report

    Report Number
    1723170-2024-02375
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 15, 2024
    Report Date
    August 27, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    UDI-DI
    00763000054403
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 9735665 (SERIAL: (B)(6) ); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 9735670 (SERIAL: (B)(6) ); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A; PRODUCT ID 9734683 (230420); PRODUCT TYPE: 2543-MNAV - SYSTEM; IMPLANT DATE N/A; EXPLANT DATE N/A 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. 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 WHEN THEY WERE USING THE TRACKERS THE SPHERES WERE FLICKERING IN AND OUT WHILE NAVIGATING. BOTH THE ORANGE AND GRAY TRACKER, AND BOTH HAD A GEOMETRY ERROR OF .49MM. THE PURPLE AND PASSIVE PLANAR PROBE WERE WORKING AS EXPECTED. THE REPRESENTATIVE RAN A STATUS CHECK ON THE CAMERA AND EVERYTHING WAS WORKING AS EXPECTED.  THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25214 NAVLOCK ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9734590 200524 00763000054403

    Patients

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