BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK GLENOID FOSSA IMPLANT

    MDR report key: 11193 · Received February 2, 1994

    Report

    Report Number
    MW1000564
    Event Type
    Injury
    Date Received
    February 2, 1994
    Date of Event
    February 16, 1988
    Report Date
    January 12, 1994
    Manufacturer
    VITEK, INC.
    Product Code
    MDL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT BILATERAL TEMPOROMANDIBULAR JOINT ARTHROPLASTY ON 5/14/86 WITH THE PLACEMENT OF 9 MM PREFORMED GLENOID FOSSA IMPLANTS. AFTER A STORMY COURSE OF 1 1/2 YRS THESE IMPLANTS WERE REMOVED 2/16/88 AND DERMAL GRAFTS PLACED. SHE CONTINUED TO DO POORLY AND ON 5/18/89, BILATERAL COSTOCHONDRAL RIB GRAFTS WERE PLACED. THERE WAS RESIDUAL FOREIGN BODY GRANULOMA AT THE SURGERY SITE 1989.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK GLENOID FOSSA IMPLANT Implant MDL VITEK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Not Applicable| H| R