BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 4X13 SELF-TAP

    MDR report key: 37693 · Received September 13, 1996

    Report

    Report Number
    2184002-1996-00179
    Event Type
    Injury
    Date Received
    September 13, 1996
    Date of Event
    August 16, 1996
    Report Date
    October 7, 1996
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS PLACED 7 MONTHS AGO IN THE MAXILLA. WHEN DR DID TRY-IN OF THE COC ABUTMENT, THE IMPLANT AND ABUTMENT BOTH CAME OUT. IMPLANT WAS NOT INTEGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 4X13 SELF-TAP Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-40-13 75950040

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention