BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM SYSTEM BONE SCREW

    MDR report key: 7960505 · Received October 12, 2018

    Report

    Report Number
    7960505
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    June 28, 2018
    Report Date
    July 10, 2018
    Manufacturer
    BIOMET MICROFIXATION, INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF THE LEFT LE FORT III FRACTURE WITH PLATES AND SCREWS. THE SURGEON REPORTED THAT ONE OF THE 6 MM SCREWS BROKE OFF AT THE HEAD THE IMPINGED SCREW WAS LEFT INSIDE OF THE ZYGOMATIC SITE OF THE FRONTAL ZYGOMATIC STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801072 1.5MM SYSTEM BONE SCREW SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION, INC

    Patients

    Seq Age Sex Outcome Treatment
    1