BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO TREPHINATION SYSTEM

    MDR report key: 236773 · Received August 13, 1999

    Report

    Report Number
    MW1017003
    Event Type
    Malfunction
    Date Received
    August 13, 1999
    Date of Event
    July 20, 1999
    Report Date
    July 26, 1999
    Manufacturer
    XOMED - TREACE, INC.
    Product Code
    KBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING LEFT FRONTAL SINUS TREPHINATION. PROBE TIP FROM TREPHINATION INSTRUMENT BROKE OFF IN LEFT FRONTAL BONE. SINUS IRRIGATED WITH SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO TREPHINATION SYSTEM MICRO TREPHINATION SYSTEM KBF XOMED - TREACE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR