BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.25MM PEDICLE PROBE

    MDR report key: 21970389 · Received May 6, 2025

    Report

    Report Number
    1723170-2025-01864
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    March 3, 2025
    Report Date
    May 6, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS WAS PERFORMED FOR PRODUCT: 9733457, LOT NUMBER: 240506. IT WAS REPORTED THAT THE TIP OF THE RETURNED PROBE WAS VISIBLY BENT. OTHERWISE, WITH MARKERS ATTACHED AND FULLY SEATED, THE PROBE DISPLAYED GOOD GEOMETRY AND DIVOT ERROR READINGS WITH NORMAL TRACKING AND VERIFICATION. CODES B01, C07 AND D02 ARE APPLICABLE. 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE CERVICAL PROBE WAS CONFIRMED TO DURING PRE-USAGE PREPARATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1885694 2.25MM PEDICLE PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733457 240909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown