BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM SYSTEM PLATE

    MDR report key: 223030 · Received May 10, 1999

    Report

    Report Number
    1032347-1999-00011
    Event Type
    Injury
    Date Received
    May 10, 1999
    Report Date
    May 7, 1999
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Product Code
    JEY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    APPROX A WEEK AFTER LEFORT PROCEDURE, REQUIRING TITANIUM PLATES TO BE IMPLANTED FOR STABILIZATION AND FIXATION OF THE SITE, THE PT WAS REPORTED TO HAVE HIT HIMSELF IN THE FACE WITH A FEEDING SYRINGE, BREAKING ONE TITANIUM L-PLATE, REQUIRING REVISION PROCEDURE TO REPLACE THE BROKEN PLATE.

    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 39 YR Required Intervention