BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.3X8 SELF-TAP

    MDR report key: 141669 · Received January 6, 1998

    Report

    Report Number
    2184002-1998-00006
    Event Type
    Injury
    Date Received
    January 6, 1998
    Date of Event
    November 11, 1997
    Report Date
    January 6, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 4/22/1997. IT FAILED AND WAS REMOVED 11/11/1997. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.3X8 SELF-TAP Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-33-08 75960472

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention