BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH 3DX

    MDR report key: 24559667 · Received March 10, 2026

    Report

    Report Number
    3003120897-2026-00397
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    November 27, 2025
    Report Date
    March 10, 2026
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS :PART # 8350312, LOT # K23H1157 VISUAL INSPECTION CONFIRMED ONE OF THE ROD HOLDER ARMS HAS BROKEN AT THE SHAFT. THE DAMAGE IS CONSISTENT WITH 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 A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION (L5-S) DUE TO SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE ROD HOLDER SUDDENLY BROKE DURING NORMAL USE. AS NO UNUSUAL HANDLING WAS INVOLVED, IT IS CONSIDERED THAT THE BREAKAGE MAY HAVE BEEN DUE TO AGING DETERIORATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623546 TSRH 3DX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC. 8350312 K23H1157 00613994282835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown