BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 6X8 SELF-TAPPING IMPLANT W/MOUNT

    MDR report key: 185582 · Received September 4, 1998

    Report

    Report Number
    2184002-1998-00571
    Event Type
    Injury
    Date Received
    September 4, 1998
    Report Date
    September 3, 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 1/15/1997. IT WAS REMOVED 9/26/1997 DUE TO INFECTION AND MOBLILITY. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 6X8 SELF-TAPPING IMPLANT W/MOUNT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-60-08 75960033

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention