BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX(TM) SYSTEM

    MDR report key: 25175467 · Received May 14, 2026

    Report

    Report Number
    3003120897-2026-00884
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Report Date
    May 14, 2026
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PRODUCT ID#:9560100, LOT#1201238:DURING THE ACCEPTANCE INSPECTION, IT WAS OBSERVED THAT THERE WAS IMAGE CLOUDING AND DAMAGE TO THE INTERNAL LENS. 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 A MANUFACTURER REPRESENTATIVE REGARDING AN ENDOSCOPE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE LENS WAS BROKEN WHEN IT WAS DROPPED DURING THE INSTRUMENT COUNT OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547659 METRX(TM) SYSTEM ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC. 9560100 1201238 00885074210353

    Patients

    Seq Age Sex Outcome Treatment
    1