BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX® SYSTEM

    MDR report key: 21072718 · Received January 3, 2025

    Report

    Report Number
    1030489-2025-00095
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    January 1, 2023
    Report Date
    January 3, 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

    H3: PRODUCT ANALYSIS #800629417:PRODUCT:9560100, ITEM:10,LOTNO:1973848 ANALYSIS CONFIRMED THAT THERE WAS A DENT IN THE OUTER TUBE AND THAT THE IMAGE WAS CLOUDY. G2: COUNTRY OF ORIGIN IS JAPAN. H11: THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 (SERVICE REPAIR, HEALTHCARE PROVIDER (HCP)) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN ENDOSCOPE HAVING SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS A VISUAL FAILURE IN THE INSTRUMENT. PATIENT SYMPTOMS WERE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT PRODUCT FOUND TO BE CLOUDY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. PRODUCT HAS BEEN USED IN PREVIOUS PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670157 METRX® SYSTEM ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC 9560100 1973848 00885074210353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown