BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES USA

    MDR report key: 279145 · Received May 24, 2000

    Report

    Report Number
    MW1018975
    Event Type
    Malfunction
    Date Received
    May 24, 2000
    Date of Event
    April 17, 2000
    Report Date
    April 17, 2000
    Manufacturer
    SYNTHES (USA)
    Product Code
    GEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERIOSTEAL ELEVATOR BROKE DURING PROCEDURE. WHILE REMOVING A SMALL BONE PLATE, MALLET USED. HANDLE CRACKED. 3 SMALL PIECES RETRIEVED. NO ADVERSE EFFECT ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES USA PERIOSTEAL ELEVATOR GEG SYNTHES (USA) 399.40 *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR