BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEHLING CE 2MM NLU-2

    MDR report key: 6293431 · Received January 30, 2017

    Report

    Report Number
    MW5067579
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    January 20, 2017
    Report Date
    January 30, 2017
    Manufacturer
    FEHLING INSTRUMENTS GMBH & CO. KG
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CERVICAL FEHLING BROKE DURING SURGERY NOTICED IN CSS. PHYSICIAN NOTIFIED. SAW SMALL METAL ON X-RAY. GOT CT SCAN. CONFIRMED METAL RETAINED. OPENED PT AT THE BEDSIDE. REPLACED PIECE OF BROKEN FEHLING. SMALLER THAN PIECE MISSING. ADD'L X-RAYS. NO OTHER METAL SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71278 FEHLING CE 2MM NLU-2 PITUITARY RONGEUR HTX FEHLING INSTRUMENTS GMBH & CO. KG CE 2MM NLU-2

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR