BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM SYSTEM PLATE

    MDR report key: 221290 · Received April 30, 1999

    Report

    Report Number
    1032347-1999-00007
    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 Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT SURGERY, IMPLANTING FOUR (4) TITANIUM L-PLATES FOR STABILIZATION AND FIXATION OF THE MAXILLA AFTER ADVANCEMENT PROCEDURE, ADVANCING MAXILLA 5MM. 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 UNKNOWN Required Intervention