BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 2013657 · Received February 24, 2011

    Report

    Report Number
    2013657
    Date Received
    February 24, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 0.5 MM W. LORENZ CRANIOMAXILLOFACIAL (CMF) SCREW SHEARED IN HALF WHILE THE SURGEON WAS HAND SCREWING THE HARDWARE INTO A PLATED HOLE THUS LEAVING THE LOWER ONE-FOURTH OF THE SCREW RETAINED IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MICRO 0.5 MM W. LORENZ CMF SCREW HWC BIOMET MICROFIXATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR