BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX® SYSTEM

    MDR report key: 19351108 · Received May 20, 2024

    Report

    Report Number
    1030489-2024-00522
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 22, 2024
    Report Date
    July 22, 2024
    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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PRODUCT ID# 9560100; LOT# 1810001 AFTER VISUAL AND OPTICAL EXAMINATION, IT APPEARS THAT MOISTURE COULD BE DETECTED INSIDE THE OPTICAL SYSTEM. TRACES OF USAGE ARE SEEN AROUND THE SCOPE. COULD BE THAT THE SCOPE WAS LEAKING AT THE PROXIMAL AS WELL AS ON THE DISTAL END. DUE TO THIS LEAKAGE, MOISTURE COULD GET INTO THE SCOPE AND INFLUENCE THE IMAGE. 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.

    Additional Manufacturer Narrative · 0

    G2: COUNTRY OF EVENT - JAPAN. 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 A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE IMAGE HAD CLOUDINESS DURING INSPECTION AND HAS POOR AIRTIGHTNESS. 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
    1146547 METRX® SYSTEM ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC 9560100 1810001 00885074210353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown