BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX® SYSTEM

    MDR report key: 21197024 · Received January 21, 2025

    Report

    Report Number
    1030489-2025-00296
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    December 19, 2024
    Report Date
    June 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 OF PRODUCT:9560100, LOTNO:1903382 THE REPORTED SYMPTOMS (CLOUDY AND DARK INSIDE AND IMAGE WAS POOR) WERE DUPLICATED. 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

    H3: PRODUCT ANALYSIS #(B)(4): PRODUCT:9560100, LOTNO:1903382 IMAGE CLOUDINESS AND BROKEN LENS WERE OBSERVED DURING THE INCOMING 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.

    Additional Manufacturer Narrative · 0

    H3 - EVALUATION OF THE RETURNED DEVICE WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETE. 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 A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING MICRO ENDOSCOPIC DISCECTOMY L4/5 FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THERE WAS DIFFICULTY IN SEEING DURING THE SURGERY. IT'S CLOUDY AND DARK INSIDE AND IMAGE WAS POOR THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722278 METRX® SYSTEM ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC 9560100 1903382 00885074210353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown