BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON TC INTERBODY SYSTEM

    MDR report key: 24567785 · Received March 11, 2026

    Report

    Report Number
    3003120897-2026-00422
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    December 11, 2024
    Report Date
    March 11, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    LXH
    UDI-DI
    00191375003793
    PMA / PMN Number
    K100889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART# 5200-1001, LOT# Y210906 VISUAL INSPECTION CONFIRMED THE TIP OF THE INSERTER HAS BEEN BENT AND THE INNER SPRING IS MISSING. THE DAMAGE TO THE INSERTER TIP IS CONSISTENT WITH BEND STRESS OVERLOAD. 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 USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING POST-OP ANTERIOR CERVICAL DISCECTOMY AND FUSION. IT WAS REPORTED THAT INSERTER BROKE AND SPIRING LOST IN SPD UPON CLEANING THE INSTRUMENT. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633438 ENDOSKELETON TC INTERBODY SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC. 5200-1001 Y210906 00191375003793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown