BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH 3DX

    MDR report key: 23645672 · Received November 25, 2025

    Report

    Report Number
    3003120897-2025-00617
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    August 27, 2025
    Report Date
    November 25, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    LXH
    UDI-DI
    00613994282835
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PART # 8350312, LOT # K22M1373 VISUAL INSPECTION CONFIRMED THE ROD HOLDER HANDLE SHAFT HAS BROKEN DUE TO 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING R EVISION SURGERY TO REMOVE NAIL AFTER BONE FUSION AFTER INITIAL PROCEDURE ON (B)(6) 2024. IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE ROD, IT WAS DIFFICULT TO EXTRACT. WHILE APPLYING SLIGHT TWISTING AND PULLING, THE ROD HOLDER FRACTURED. REVISION SURGERY WAS NOT DUE TO MEDTRONIC PRODUCT MALFUNCTION. THE REMOVAL OF SCREWS AFTER BONE UNION, WHICH WAS ORIGINALLY SCHEDULED. THERE WAS A DELAY OF LESS THAN 60 MINS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2833730 TSRH 3DX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC. 8350312 K22M1373 00613994282835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown