BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSTAIN 3.3X10 HA CYLINDER IMPLANT

    MDR report key: 188593 · Received September 24, 1998

    Report

    Report Number
    2184002-1998-00688
    Event Type
    Injury
    Date Received
    September 24, 1998
    Date of Event
    August 28, 1998
    Report Date
    September 24, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 8/11/1997 IN THE UPPER MAXILLA. IT WAS REMOVED DUE TO MOBILITY ON 8/28/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUSTAIN 3.3X10 HA CYLINDER IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. 410030-33-10 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention