BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK SYSTEMS

    MDR report key: 458680 · Received May 7, 2003

    Report

    Report Number
    MW1028372
    Event Type
    Malfunction
    Date Received
    May 7, 2003
    Date of Event
    April 16, 2003
    Report Date
    May 7, 2003
    Manufacturer
    WECK SYSTEMS
    Product Code
    KDG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OSTEOTOME -6MM- BROKE DURING USE SEPTORHINOPLASTY - NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK SYSTEMS SCRAPING DEVICE KDG WECK SYSTEMS 6MM OSTEOTOME *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR