BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 6X8 SELF-TAPPING IMPLANT WITH MOUNT

    MDR report key: 183050 · Received August 19, 1998

    Report

    Report Number
    2184002-1998-00530
    Event Type
    Injury
    Date Received
    August 19, 1998
    Date of Event
    October 11, 1997
    Report Date
    August 18, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 5/7/1997. IT FAILED DUE TO MOBILITY AND WAS REMOVED 10/11/1997. ONE PERSON AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention