BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 1180343 · Received September 30, 2008

    Report

    Report Number
    1180343
    Date Received
    September 30, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EJL
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE THE PHYSICIAN WAS DRILLING IN THE MANDIBLE, THE DRILL BIT BROKE LEAVING A PIECE OF THE BIT IN THE PATIENT'S MANDIBLE. SURGERY WAS PROLONGED FOR 2 HOURS TO ALLOW THE PHYSICIAN TO RETRIEVE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * DENTAL DRILL BIT EJL BIOMET MICROFIXATION 01-9198 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR