BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMAONE SYSTEM

    MDR report key: 6355984 · Received February 24, 2017

    Report

    Report Number
    6355984
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    January 21, 2017
    Report Date
    February 7, 2017
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE BEING DONE IS BILATERAL MANDIBLE ORIF. WHILE DRILLING ON THE RIGHT MANDIBLE, THE DRILL BIT BROKE AND A PIECE WAS LEFT IN THE MANDIBLE. THE SURGEON WAS ABLE TO RETRIEVE /REMOVED THE BIT OF DRILL BIT FROM THE MANDIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139127 TRAUMAONE SYSTEM DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION, INC. 46-1004

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR