BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSTAIN 3.3X13 HA CYLINDER IMPLANT

    MDR report key: 183027 · Received August 19, 1998

    Report

    Report Number
    2184002-1998-00534
    Event Type
    Injury
    Date Received
    August 19, 1998
    Report Date
    August 19, 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

    IMPLANTS PLACED 6/11/1997. THEY FAILED DUE TO INFECTION, PAIN, MOBILITY AND WERE REMOVED. REMOVAL DATE IS UNKNOWN. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUSTAIN 3.3X13 HA CYLINDER IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. 410030-33-13 75971311

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention