BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX® SYSTEM

    MDR report key: 21537631 · Received March 6, 2025

    Report

    Report Number
    1030489-2025-01224
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Report Date
    March 6, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART: (B)(6), LOT NO:1092732 DURING THE INSPECTION AT THE TIME OF ACCEPTANCE, IT WAS OBSERVED THAT THE OUTER TUBE AND THE LENS AT THE TIP OF THE OUTER TUBE WERE SCRATCHED, THE INTERNAL LENS WAS BROKEN, AND THE IMAGE WAS CLOUDY. 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 AN A PATIENT HAVING MED DUE TO SPINAL DISC HERNIATION. IT WAS REPORTED THAT IT WAS IT DIFFICULT TO SEE AND LENS WAS FOUND CRACKED DURING POSTOPERATIVE CHECK. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827959 METRX® SYSTEM ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC 9560100 1092732 00885074210353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown