BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.25MM PEDICLE PROBE

    MDR report key: 22730181 · Received August 6, 2025

    Report

    Report Number
    1723170-2025-02919
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    May 16, 2025
    Report Date
    August 6, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000121198
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G2: FOREIGN COUNTRY - JAPAN. H3, H6: THE 9733457 PROBE, LOT NUMBER: 170905, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WAS PHYSICAL DAMAGE. THE PROBE BENT, OTHERWISE IT WAS FULLY FUNCTIONAL. 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. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE PROBE, WHICH WAS RETURNED DUE TO THE END OF THE LOAN PERIOD, WAS FOUND TO HAVE A DEFORMED TIP DURING THE ACCEPTANCE INSPECTION. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568790 2.25MM PEDICLE PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9733457 170905 00763000121198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown