BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON¿ TT INTERBODY SYSTEM

    MDR report key: 23678032 · Received December 1, 2025

    Report

    Report Number
    3011577940-2025-00019
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    May 12, 2025
    Report Date
    December 1, 2025
    Manufacturer
    TITAN SPINE, A DIVISION OF MEDTRONIC
    Product Code
    HWR
    UDI-DI
    00191375002987
    PMA / PMN Number
    K083714
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PRODUCT: 4200-1001, LOT: N140501 VISUAL AND OPTICAL INSPECTION CONFIRMED THE TIP OF THE IMPLANT HOLDER HAS BROKEN. THE DAMAGE TO THE INSTRUMENT IS CONSISTENT WITH OVERLOAD. 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

    INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE THREADED TIP OF THE HOLDER BROKE OFF. THE PRODUCT WAS NOT IMPLANTABLE, AND NO FRAGMENT OF THE INSTRUMENT REMAINED IN A PATIENT. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2800989 ENDOSKELETON¿ TT INTERBODY SYSTEM DRIVER, PROSTHESIS HWR TITAN SPINE, A DIVISION OF MEDTRONIC 4200-1001 N140501 00191375002987

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown