BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.25MM PEDICLE PROBE

    MDR report key: 22890090 · Received August 25, 2025

    Report

    Report Number
    1723170-2025-03060
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    September 4, 2024
    Report Date
    August 25, 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

    H3, H6: THE PROBE, LOT NUMBER: 221226, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. TIP WAS SIGHTLY BENT. GOOD GEOMETRY AND DIVOT ERROR READINGS. 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 INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT DEFORMED DURING USE IN A SCOLIOSIS OPERATION. IT WAS BELIEVED THAT THE INSTRUMENT WAS USED IN A HARD PART OF THE BONE. THE OPERATION WAS COMPLETED BY USING ANOTHER INSTRUMENT. NO KNOWN IMPACT TO PATIENT OUTCOME. THERE WAS NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552962 2.25MM PEDICLE PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9733457 221226 00763000121198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown