BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 21009720 · Received December 24, 2024

    Report

    Report Number
    1030489-2024-01740
    Event Type
    Malfunction
    Date Received
    December 24, 2024
    Date of Event
    November 19, 2024
    Report Date
    March 12, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HRX
    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:1201219 - DURING THE INCOMING INSPECTION, THE REQUESTED PHENOMENON WAS OBSERVED, THE SCRATCHES ON THE OUTER TUBE, THE BROKEN INNER LENS, AND THE COUPLER WAS LOOSE. 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: ITEM NO:9560100, LOT NO:1201219. DURING THE INCOMING INSPECTION, THE REQUESTED PHENOMENON WAS OBSERVED, THE OUTER TUBE WAS DAMAGED, THE INNER LENS WAS DAMAGED, AND THE COUPLER WAS LOOSE. 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 HCP VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING ENDOSCOPIC HERNIECTOMY FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE ENDOSCOPE LENS BECAME WHITE & BLURRY DURING USAGE. NO PATIENT SYMPTOMS WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2496953 METRX ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC 9560100 1201219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown