BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSTAIN 3.4X13 HA EXTERNAL HEX IMPLANT

    MDR report key: 196319 · Received November 11, 1998

    Report

    Report Number
    2184002-1998-00776
    Event Type
    Injury
    Date Received
    November 11, 1998
    Date of Event
    October 13, 1998
    Report Date
    November 11, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 05/15/1998. IT FAILED DUE TO INFECTION AND WAS REMOVED 10/13/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUSTAIN 3.4X13 HA EXTERNAL HEX IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. 410030-34-13 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention