BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 4X13 TPS CYLINDER

    MDR report key: 144818 · Received January 21, 1998

    Report

    Report Number
    2184002-1998-00047
    Event Type
    Injury
    Date Received
    January 21, 1998
    Date of Event
    November 21, 1997
    Report Date
    January 21, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 9/2/1997. WHEN UNCOVERED 11/21/1997, IT WAS FOUND TO BE LOOSE AND WAS REMOVED. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 4X13 TPS CYLINDER Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9040-40-13 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention