BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 4X13 TPS CYLINDER IMPLANT

    MDR report key: 188215 · Received September 21, 1998

    Report

    Report Number
    2184002-1998-00667
    Event Type
    Injury
    Date Received
    September 21, 1998
    Date of Event
    June 4, 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
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 05/19/1998 INTO SITE #19. IT WAS REMOVED 06/04/1998 DUE TO MOBILITY AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 4X13 TPS CYLINDER IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9040-40-13 75971721

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention