BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK

    MDR report key: 21636738 · Received March 18, 2025

    Report

    Report Number
    1723170-2025-01355
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    January 23, 2025
    Report Date
    March 18, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K171267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS WAS PERFORMED FOR PRODUCT: 9734683, LOT NUMBER: 230103. IT WAS REPORTED THAT ONE OF THE TWO SIDE TABS WAS MISSING ON THE RETURNED TRACKER. OTHERWISE, WITH MARKERS ATTACHED AND FULLY SEATED, THE TRACKER DISPLAYED GOOD GEOMETRY AND DIVOT ERROR READINGS WITH NORMAL TRACKING AND VERIFICATION. CODES B01, C07 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 DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT ORANGE NAVLOCK WAS DAMAGED. THE PROCEDURE WAS CONTINUED USING A DIFFERENT TRACKER. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND NO REPORTED DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592439 NAVLOCK ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9734683 230103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown