BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON¿ TT INTERBODY SYSTEM

    MDR report key: 24557458 · Received March 10, 2026

    Report

    Report Number
    3003120897-2026-00393
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    October 1, 2024
    Report Date
    March 10, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    HWR
    UDI-DI
    00191375030195
    PMA / PMN Number
    K083714
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART # 4200-1035, LOT # Y161228 VISUAL AND OPTICAL INSPECTION CONFIRMED THE THREADS OF THE STRAIGHT INSERTER HAVE BEEN DAMAGED/BROKEN. THE DAMAGE APPEARS TO BE FROM FROM OVERLOAD DURING THE REMOVAL PROCESS OF ONE OF THE CAGES. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW. 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS WAS LUMBAR STENOSIS. IT WAS REPORTED THAT, THE TT INSERTER WAS USED TO PLACE THE CAGE. THEN IT WAS USED TO REATTACH TO BACK CAGE OUT. IN THE PROCESS THE INNER SHAFT¿S THREADED TIP WAS DAMAGED. LEVELS TREATED WERE L5-S1. PROCEDURE OR TECHNIQUE PERFORMED WAS POSTERIOR LUMBAR INTERBODY FUSION/TRANSFORAMINAL LUMBAR INTERBODY FUSION. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED. PIECE OF THREAD FROM INSERTER TIP WAS SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39138 ENDOSKELETON¿ TT INTERBODY SYSTEM DRIVER, PROSTHESIS HWR MEDTRONIC SOFAMOR DANEK USA, INC. 4200-1035 Y161228 00191375030195

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female