BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX(TM) SYSTEM

    MDR report key: 24968661 · Received April 23, 2026

    Report

    Report Number
    3003120897-2026-00762
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Report Date
    April 23, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    HRX
    UDI-DI
    00673978085456
    PMA / PMN Number
    K993021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS UNKNOWN. H3: PRODUCT ANALYSIS # (B)(4), PRODUCT:9560101,LOT NO:1911292 ANALYSIS CONFIRMED THAT THAT THERE WERE SCRATCHES ON THE OUTER TUBE AND CLOUDING OF THE IMAGE DURING THE ACCEPTANCE INSPECTION. 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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY, SERVICE REPAIR) REGARDING A ENDOSCOPE US ED FOR SPINAL THERAPY. IT WAS REPORTED THAT INSPECTION WAS REQUESTED FOR INSTRUMENT DUE TO CLOUDINESS(NOT CLEAR). IT IS STILL UNKNOWN WHETHER THE PATIENT IS INVOLVED OR NOT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619438 METRX(TM) SYSTEM ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC. 9560101 1911292 00673978085456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown