BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSKELETON TC INTERBODY SYSTEM WITH TITAN NANOLOCK SURFACE TECHNOLOGY

    MDR report key: 23345589 · Received October 21, 2025

    Report

    Report Number
    3011577940-2025-00015
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 15, 2025
    Manufacturer
    TITAN SPINE, A DIVISION OF MEDTRONIC
    Product Code
    ODP
    UDI-DI
    00191375013051
    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

    ADDITIONAL INFORMATION: D9, H3, H6 H3. DEVICE EVALUATION SUMMARY: PRODUCT ANALYSIS # (B)(4): PART # 5166-1405-N LOT # TM0149328 VISUAL AND OPTICAL INSPECTION DID NOT REVEAL ANY DAMAGE TO THE SPACER. FUNCTIONAL INSPECTION CONFIRMED THE SPACER WAS ABLE TO BE ATTACHED AND RELEASE FROM A SAMPLE INSERTER WITHOUT ANY ISSUE. 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

    G2: THE COUNTRY OF THE EVENT 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

    ADDITIONAL INFORMATION: H11 RADIOGRAPHIC IMAGE REVIEW: THE LATERAL X-RAY OF C3-4 ACDF WAS PROVIDED. THE INTERBODY DEVICE IS TRANSLATED ANTERIORLY. NO FIXATION DEVICE IS PRESENT. 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 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE AT THE HWK 3/4 LEVEL FOR AN INDICATION OF HERNIATED DISC AT HWK 3/4. IT WAS REPORTED THAT THE CAGE BECAME LOOSE AND SLIPPED, AND THE PATIENT DID NOT ACHIEVE SOLID FUSION. THE ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2025 TO EXPLANT THE CAGE. THE PATIENT WAS HAVING SLIGHT DISCOMFORT WHEN SWALLOWING AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783287 ENDOSKELETON TC INTERBODY SYSTEM WITH TITAN NANOLOCK SURFACE TECHNOLOGY INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, ODP TITAN SPINE, A DIVISION OF MEDTRONIC 5166-1405-N TM0149328 00191375013051

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention