BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.75X10 SELF-TAPPING IMPLANT

    MDR report key: 190011 · Received October 2, 1998

    Report

    Report Number
    2184002-1998-00696
    Event Type
    Injury
    Date Received
    October 2, 1998
    Date of Event
    December 3, 1997
    Report Date
    October 1, 1998
    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

    IMPLANTS WERE PLACED 02/26/1997. THEY FAILED AND WERE REMOVED 12/03/1997. NO FURTHER INFO REC'D. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.75X10 SELF-TAPPING IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9005-38-10 75950380

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention