BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.25MM PEDICLE PROBE

    MDR report key: 24948641 · Received April 21, 2026

    Report

    Report Number
    1723170-2026-00635
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 21, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: ANALYSIS WAS PERFORMED FOR PRODUCT: 9733457, LOT NUMBER: 191107. IT WAS REPORTED THAT AS REPORTED, THE TIP OF THE RETURNED PROBE WAS VISIBLY BENT. WITH MARKERS ATTACHED AND FULLY SEATED, THE PROBE DISPLAYED A GOOD GEOMETRY ERROR BUT A HIGH DIVOT ERROR DUE TO THE BENT TIP. 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. 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 INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE PEDICLE PROBE WAS DEFORMED. THE CAUSE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED USING A DIFFERENT INSTRUMENT. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6406 2.25MM PEDICLE PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9733457 191107 00763000504304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown