BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT WIRE FORMING PLIER WITH CUTTER

    MDR report key: 1081154 · Received July 10, 2008

    Report

    Report Number
    1081154
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 10, 2008
    Manufacturer
    ORTHOPLI CORP
    Product Code
    JEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE PLIERS USED TO BEND DENTAL BAND BROKE AT THE TIP ON ONE SIDE, WHILE IN THE PATIENT'S MOUTH. THE SURGEON EXAMINED THE ORAL CAVITY TO ASSURE NO METAL WAS SEEN. ORAL CAVITY ALSO FLUSHED OUT WITH WATER. NO METAL INSTRUMENTS TIP FOUND. PATIENT DISCHARGED HOME WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHT WIRE FORMING PLIER WITH CUTTER PLIERS, DENTAL JEX ORTHOPLI CORP 032-GC *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR NO OTHER THERAPIES| NO OTHER THERAPIES