BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.75X15 SELF-TAPPING IMPLANT WITH MOUNT

    MDR report key: 186580 · Received September 11, 1998

    Report

    Report Number
    2184002-1998-00608
    Event Type
    Injury
    Date Received
    September 11, 1998
    Report Date
    August 14, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 6/11/1997. IT FAILED DUE TO MOBILITY AND WAS REMOVED 3/4/1998. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.75X15 SELF-TAPPING IMPLANT WITH MOUNT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-38-15 75971199

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention