BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.4X13 TPS CYLIND

    MDR report key: 153203 · Received March 2, 1998

    Report

    Report Number
    2184002-1998-00143
    Event Type
    Injury
    Date Received
    March 2, 1998
    Date of Event
    February 2, 1997
    Report Date
    February 27, 1998
    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 PLACED 11/1997. IT FAILED AND WAS REMOVED 2/2/98. 1 PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.4X13 TPS CYLIND Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9040-34-13 75971010

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention