BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSKELETON¿ TC INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY

    MDR report key: 23354879 · Received October 22, 2025

    Report

    Report Number
    3011577940-2025-00016
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 20, 2025
    Report Date
    December 16, 2025
    Manufacturer
    TITAN SPINE, A DIVISION OF MEDTRONIC
    Product Code
    ODP
    UDI-DI
    00191375013068
    PMA / PMN Number
    K141953
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: COUNTRY OF ORIGIN IS GERMANY. 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

    RADIOGRAPHIC IMAGE ASSESSMENT CONCLUDED THAT LATERAL FLUORO IMAGES SHOWS ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). SAGITTAL CT SHOWS INTERBODY GRAFT AT C4-5 AND C5-6. THE C4-5 GRAFT APPEARS ANTERIOR. 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243784 ENDOSKELETON¿ TC INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, ODP TITAN SPINE, A DIVISION OF MEDTRONIC 5166-1406-N TM0153739 00191375013068

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention