BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK

    MDR report key: 23268827 · Received October 10, 2025

    Report

    Report Number
    1723170-2025-03433
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    May 29, 2025
    Report Date
    October 10, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE PROBE, LOT NUMBER: 241127, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE TIP OF INSTRUMENT WAS BENT. THE REPORTED EVENT COULD BE DUPLICATED BY MEDTRONIC PERSONNEL. 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 PREOPERATIVELY. IT WAS REPORTED THAT DURING THE PRE-USE INSPECTION, DISTORTION WAS IDENTIFIED ON THE INSTRUMENT TIP. A DIFFERENT INSTRUMENT WAS USED. THERE WAS NO PATIENT INVOLVEMENT. THE SUSPECTED AND MOST LIKELY CAUSE OF THIS ISSUE WAS THAT WHEN ADVANCING WITH THE THORACIC PROBE, THERE WERE TIMES WHEN A SIGNIFICANT AMOUNT OF FORCE WAS APPLIED. COMPARED TO THE LUMBAR PROBE, THE THORACIC PROBE IS SLIGHTLY THINNER, AND SINCE THE BONE STRENGTH BETWEEN THE THORACIC AND LUMBAR REGIONS DOES NOT DIFFER SIGNIFICANTLY (INDIVIDUAL DIFFERENCES AND INSERTION POSITION ARE MORE INFLUENTIAL FACTORS), IT IS PRESUMED THAT, WHEN THE SAME AMOUNT OF FORCE IS APPLIED, THE THORACIC PROBE MAY BE SLIGHTLY MORE PRONE TO BENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280606 NAVLOCK ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 9734680 241127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown