BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.3X15 SELF-TAPPING IMPLANT WITH MOUNT

    MDR report key: 186579 · Received September 11, 1998

    Report

    Report Number
    2184002-1998-00609
    Event Type
    Injury
    Date Received
    September 11, 1998
    Report Date
    August 14, 1998
    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 4/25/1997. IT WAS REMOVED 3/11/1998 DUE TO MOBILITY. ONE PERSON AFFECTED.

    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 75950622

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention