BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.75X10 SELF-TAP+

    MDR report key: 36354 · Received August 30, 1996

    Report

    Report Number
    2184002-1996-00165
    Event Type
    Injury
    Date Received
    August 30, 1996
    Date of Event
    August 7, 1996
    Report Date
    August 29, 1996
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.75X10 SELF-TAP+ Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-38-10 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention