BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATED CD HORIZON TAP

    MDR report key: 21370273 · Received February 12, 2025

    Report

    Report Number
    1723170-2025-00649
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    July 17, 2024
    Report Date
    February 12, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    UDI-DI
    00613994724113
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE TAP 9734296 3.75 WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS REPORTED THAT THE TIP OF THE RETURNED TAP IS BENT. 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

    2024-JUL-17 MPXR 00833777, 1203148 (REP, HCP, FOR): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS TIP DEFORMATION OF THE TAPS. THE OPERATION WAS COMPLETED BY USING A SPAR TAP INSTEAD. NO SURGICAL DELAY. NO KNOWN IMPACT TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984587 NAVIGATED CD HORIZON TAP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9734296 150820 00613994724113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown