BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.75X13 SELF TAP+

    MDR report key: 39255 · Received September 24, 1996

    Report

    Report Number
    2184002-1996-00199
    Event Type
    Injury
    Date Received
    September 24, 1996
    Date of Event
    July 1, 1996
    Report Date
    October 8, 1996
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 10/3/96, UPPER. FAILED, WITH TEMPORARY ABUTMENT IN PLACE, ON 7/1/96. PT HAS HAD A TOTAL OF 6 IMPLANTS PLACED. ALL UPPER. A TOTAL OF 5 HAVE NOW FAILED-REF 96-402B AND 96-402C. ONE IMPLANT EACH. THE OTHER 2 WERE PREVIOUSLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.75X13 SELF TAP+ Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-38-13 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention