BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT-FITTED TMJ RECONSTRUCTION PROSTHESIS

    MDR report key: 595795 · Received April 25, 2005

    Report

    Report Number
    2031049-2005-00020
    Event Type
    Injury
    Date Received
    April 25, 2005
    Date of Event
    March 23, 2005
    Report Date
    April 22, 2005
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF LEFT TMJ FOSSA AND MANDIBULAR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT-FITTED TMJ RECONSTRUCTION PROSTHESIS TMJ IMPLANT LZD TMJ SOLUTIONS, INC. TYY-NNN W06941

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention