BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LORENZ

    MDR report key: 1691220 · Received April 28, 2010

    Report

    Report Number
    1691220
    Event Type
    Malfunction
    Date Received
    April 28, 2010
    Date of Event
    March 15, 2010
    Report Date
    April 22, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    DZN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, PHYSICIAN WAS UTILIZING ELEVATOR TO REMOVE TOOTH. THE TIP OF THE INSTRUMENT BROKE DURING THE PROCEDURE. PHYSICIAN RETREIVED THE TIP AND ENSURED NO HARM WAS DONE TO THE PATIENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LORENZ ELEVATOR DZN BIOMET MICROFIXATION 09-0257-ELEVATOR #301 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR NO OTHER THERAPIES