BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEMS

    MDR report key: 277587 · Received May 15, 2000

    Report

    Report Number
    1721760-2000-00005
    Event Type
    Injury
    Date Received
    May 15, 2000
    Date of Event
    March 21, 2000
    Report Date
    April 17, 2000
    Manufacturer
    TMJ IMPLANTS, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RECEIVED LETTER FROM EXPLANTING SURGEON STATING THE REASON FOR EXPLANT WAS DUE TO THE LOOSENING OF THE DEVICE. AT THE TIME OF SURGERY, THE SURGEON STATED THAT IT APPEARED THAT THE SCREWS HAD NOT ORIGINALLY BEEN PUT INTO SOLID BONE BUT, ON THE PERIPHERY OF THE BONE WHICH ALLOWED IT TO LOOSEN RAPIDLY AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEMS TEMPOROMANDIBULAR JOINT PROSTHESIS SYSTEM LZD TMJ IMPLANTS, INC. NA 0033

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention