BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 6X10 SELF-TAP+

    MDR report key: 36278 · Received September 3, 1996

    Report

    Report Number
    2184002-1996-00166
    Event Type
    Injury
    Date Received
    September 3, 1996
    Date of Event
    April 16, 1996
    Report Date
    August 30, 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

    IMPLANT WAS PLACED ON 7/11/95. NO GRAFTING OR OTHER EXTENUATING CIRCUMSTANCES. ONE ABUTMENT WAS IN FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 6X10 SELF-TAP+ Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL INC. R9010-60-10 75950118

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention