BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK

    MDR report key: 23353819 · Received October 21, 2025

    Report

    Report Number
    1723170-2025-03510
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    July 24, 2025
    Report Date
    October 21, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    UDI-DI
    00763000054205
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE THORACIC PROBE, LOT NUMBER: 250317, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE TIP OF THE RETURNED PROBE WAS TWISTED. THERE WAS ALSO GALLING MARKS ON THE BACK END. THE REPORTED EVENT WAS DUPLICATED AND A PHYSICAL DAMAGE FAILURE MODE WAS IDENTIFIED. 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 SYSTEM BEING USED FOR AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT A THORACIC PROBE THAT WAS RECENTLY PURCHASED WAS FOUND TO BE BENT DURING A PROCEDURE. LENGTH OF DELAY WAS UNKNOWN. IMPACT ON PATIENT OUTCOME UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT A SACROILIAC AND THORACOLUMBAR PROCEDURE WAS PERFORMED, THE ISSUE WAS NOTICED POST-OPERATIVE, THERE WAS NO IMPACT ON PATIENT OUTCOME, AND THERE WAS NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236610 NAVLOCK ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 9734680 250317 00763000054205

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male