BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 6X13 SELF-TAPPING

    MDR report key: 36527 · Received September 4, 1996

    Report

    Report Number
    2184002-1996-00171
    Event Type
    Injury
    Date Received
    September 4, 1996
    Date of Event
    August 4, 1995
    Report Date
    September 4, 1996
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ONE IMPLANT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 6X13 SELF-TAPPING Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-60-13 75950119

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention