BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATED CANNULATED 4.5MM TAP

    MDR report key: 23646977 · Received November 25, 2025

    Report

    Report Number
    1723170-2025-03809
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    August 25, 2025
    Report Date
    November 25, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    UDI-DI
    00763000076627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE TAP, LOT NUMBER: 240327, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE TAP WAS FOUND TO BE BROKEN OFF AT THE TIP. H6: 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 NAV TAP WAS BROKEN. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. IT WAS REPORTED THAT THE TAP BROKE OFF IN THE PEDICLE AND STILL REMAINS IN THE PATIENT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568285 NAVIGATED CANNULATED 4.5MM TAP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 9734298 240327 00763000076627

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female