BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSTAIN 3.3X15 HA CYLINDER IMPLANT

    MDR report key: 187556 · Received September 17, 1998

    Report

    Report Number
    2184002-1998-00642
    Event Type
    Injury
    Date Received
    September 17, 1998
    Date of Event
    November 1, 1997
    Report Date
    September 17, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO INFECTION AND WAS REMOVED 11/1997. IMPLANT HAD BEEN PLACED A YEAR PREVIOUSLY, DATE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUSTAIN 3.3X15 HA CYLINDER IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. 410030-33-15 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention