BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX SYSTEM

    MDR report key: 19496128 · Received June 10, 2024

    Report

    Report Number
    1030489-2024-00639
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 10, 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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS : AIR OF PRODUCT ID: 9560100, SERIAL/LOT #: (B)(6): DURING THE INSPECTION AT THE TIME OF ACCEPTANCE, THE REQUESTED PHENOMENON WAS REPRODUCED AND IT WAS OBSERVED THAT THE OUTER TUBE WAS BROKEN AND THE LIGHT POST WAS LOOSE. AIR OF PRODUCT ID: 9560100, SERIAL/LOT # (B)(6): DURING THE INSPECTION AT THE TIME OF ACCEPTANCE, THE REQUESTED PHENOMENON WAS REPRODUCED AND IT WAS OBSERVED THAT THERE WERE SCRATCHES ON THE OUTER TUBE. AIR OF PRODUCT ID: 9560101, SERIAL/LOT #: (B)(6): DURING THE INSPECTION AT THE TIME OF ACCEPTANCE, THE REQUESTED PHENOMENON WAS REPRODUCED. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9560100, SERIAL/LOT #: (B)(6), UDI#: (B)(4), 510K: K002931; PRODUCT ID: 9560101, SERIAL/LOT #: (B)(6), UDI#: (B)(4). 510K: K993021. 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 SERVICE AND REPAIR VIA MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR ENDOSCOPIC SPINE SURGERY. IT WAS REPORTED THAT IT WAS DIFFICULT TO SEE. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. 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
    2124971 METRX SYSTEM ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC 9560100 1201227 00885074210353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown