BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 4X7MM SELF-TAP+

    MDR report key: 36332 · Received August 30, 1996

    Report

    Report Number
    2184002-1996-00160
    Event Type
    Injury
    Date Received
    August 30, 1996
    Date of Event
    July 16, 1996
    Report Date
    August 29, 1996
    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 FAILED TO INTEGRATE. PER DR, PT IS A SMOKER AND IN GOOD GENERAL HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 4X7MM SELF-TAP+ Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-40-07 75960190

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention