BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4206066 · Received October 28, 2014

    Report

    Report Number
    9680837-2014-00089
    Event Type
    Malfunction
    Date Received
    October 28, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S
    Product Code
    GEG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT ANALYSIS DETERMINED ¿THE ELEVATOR IS BROKEN NEXT TO THE TIG WELDING AREA. THERE IS NO MISSING FRAGMENT.¿ RESULTS: FRACTURE PROBLEM. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688967 MICROFRANCE® INSTRUMENT ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY GEG MEDTRONIC XOMED INSTRUMENTATION S.A.S CP845 120901

    Patients

    Seq Age Sex Outcome Treatment
    1