BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 178836 · Received July 24, 1998

    Report

    Report Number
    178836
    Event Type
    Injury
    Date Received
    July 24, 1998
    Date of Event
    July 9, 1998
    Report Date
    July 22, 1998
    Manufacturer
    UNK
    Product Code
    LZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP REPORT TO INFORM FDA THAT FACILITY HAS MADE NUMEROUS ATTEMPTS TO GET ALL NECESSARY INFORMATION TO COMPLETE THIS REPORT FROM THE HOSPITAL THAT PERFORMED THE IMPLANT AS WELL AS THE PT'S CURRENT PHYSICIAN. ALL ATTEMPTS HAVE BEEN TO NO AVAIL AND THEREFORE THIS REPORT REMAINS INCOMPLETE. THE FILING OF THIS REPORT IS TO COMPLY WITH THE SMDA WITH THE INTENT TO IMPROVE THE QUALITY OF THE CARE THE PATIENTS RECEIVE. BY FILING THIS REPORT, THE OSU HOSPITALS DOES NOT ADMIT FAULT OR LIABILITY ON BEHALF OF ITS EMPLOYEES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant TOTAL TMJ PROSTHESIS LZD UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention