BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 4X8 SELF-TAPPING IMPLANT

    MDR report key: 186277 · Received September 10, 1998

    Report

    Report Number
    2184002-1998-00601
    Event Type
    Injury
    Date Received
    September 10, 1998
    Date of Event
    July 2, 1998
    Report Date
    September 10, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS PLACED 5/29/98. IT WAS REMOVED DUE TO MOBILITY ON 07/02/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 4X8 SELF-TAPPING IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9005-40-08 75981147

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention