BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX® SYSTEM

    MDR report key: 23766665 · Received December 10, 2025

    Report

    Report Number
    3003120897-2025-00716
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 10, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    HRX
    UDI-DI
    00885074210353
    PMA / PMN Number
    K002931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER DETAILS ARE UNKNOWN G2: COUNTRY OF ORIGIN IS JAPAN H3: PRODUCT ANALYSIS - PRODUCT: (B)(4), LOTNO: 1093115 DURING THE INSPECTION AT THE TIME OF ACCEPTANCE, IT WAS OBSERVED SCRATCHES ON THE OUTER TUBE, THE IMAGE WAS CLOUDY, AND THE INTERNAL LENS WAS BROKEN. 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 SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS A DENT IN THE SCOPE, COULD NOT ADJUST THE FOCUS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TYPE OF PROCEDURE/THERAPY INVOLVED DURING THE EVENT WAS L4/5 MICROENDOSCOPIC LAMINECTOMY (MEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041908 METRX® SYSTEM ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC. 9560100 1093115 00885074210353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown