BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 4X10 TPS CYLINDER

    MDR report key: 162334 · Received April 14, 1998

    Report

    Report Number
    2184002-1998-00257
    Event Type
    Injury
    Date Received
    April 14, 1998
    Date of Event
    February 25, 1998
    Report Date
    April 14, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 11/18/1997. IT DID NOT INTEGRATE AND WAS REMOVED 2/25/1998. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 4X10 TPS CYLINDER Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9040-40-10 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention