BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.3X15 SELF-TAPPING IMPLANT WITH MOUNT

    MDR report key: 188227 · Received September 21, 1998

    Report

    Report Number
    2184002-1998-00665
    Event Type
    Injury
    Date Received
    September 21, 1998
    Date of Event
    August 7, 1998
    Report Date
    September 21, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 10/30/1997. IT FAILED TO INTEGRATE AND WAS REMOVED 08/07/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.3X15 SELF-TAPPING IMPLANT WITH MOUNT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-33-15 75970175

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention