BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM SYSTEM PLATE

    MDR report key: 221298 · Received April 30, 1999

    Report

    Report Number
    1032347-1999-00009
    Event Type
    Injury
    Date Received
    April 30, 1999
    Report Date
    April 29, 1999
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Product Code
    JEY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT SURGERY IMPLANTING FOUR (4) TITANIUM L-PLATES FOR STABILIZATION AND FIXATION OF THE MAXILLA APPROXIMATELY 5 MM. THE PLATES BROKE, REQUIRING REVISION SURGERY TO REPLACE THE BROKEN PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5MM SYSTEM PLATE Implant TITANIUM BONE PLATE JEY WALTER LORENZ SURGICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention