BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.25MM PEDICLE PROBE

    MDR report key: 23957539 · Received January 5, 2026

    Report

    Report Number
    1723170-2026-00020
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    November 13, 2025
    Report Date
    January 5, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000504304
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE PROBE, LOT NUMBER: 191107, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE TIP OF THE RETURNED PROBE WAS SLIGHTLY BENT. WITH MARKERS ATTACHED AND FULLY SEATED, THE PROBE HAD NORMAL TRACKING, BUT THE DIVOT ERROR WAS HIGH DUE TO THE BENT TIP AND WOULD NOT VERIFY. THE REPORTED EVENT COULD BE DUPLICATED BY MEDTRONIC PERSONNEL. CODES B01, C13, 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 DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE CERVICAL PROBE WAS FOUND TO BE DEFORMED, WHICH WAS CONSIDERED TO BE DUE TO USE. THE OPERATION WAS COMPLETED USING ANOTHER INSTRUMENT. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WERE TWO PROBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19550 2.25MM PEDICLE PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9733457 191107 00763000504304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown