BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 924268 · Received September 28, 2007

    Report

    Report Number
    MW5003943
    Event Type
    Injury
    Date Received
    September 28, 2007
    Date of Event
    September 28, 2007
    Report Date
    September 28, 2007
    Manufacturer
    TMJ CONCEPTS
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FRACTURE OF FOSSA COMPONENT OF TMJ CONCEPTS DEVICE. DATES OF USE: 1998 - 2007. DIAGNOSIS OR REASON FOR USE: FAILED AUTOGENOUS RIB GRAFT TO RIGHT TMJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ CONCEPTS TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION LZD TMJ CONCEPTS 98-039

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization