BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC STEREOTAXIC INSTRUMENT

    MDR report key: 22146409 · Received June 4, 2025

    Report

    Report Number
    1723170-2025-02205
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    February 7, 2025
    Report Date
    June 17, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    UDI-DI
    00763000214289
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H2, CORRECTION: THE AWARE DATE OF THE PREVIOUS MDR SHOULD HAVE BEEN 2025-02-07. 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.

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS WAS PERFORMED FOR PRODUCT: 9735278, LOT NUMBER: 210318. IT WAS REPORTED THAT THE TIP OF THE RETURNED DRIVER HAD BEEN BROKEN OFF. 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 SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED INTRAOPERATIVELY DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE. THE TIP OF THE DRIVER BROKE WHILE BEING USED INSIDE OF THE PATIENT. HOWEVER, THE TIP WAS RETRIEVED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80215 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9735278 210318 00763000214289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown