BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSTAIN 4X13 HA CYLINDER IMPLANT

    MDR report key: 204019 · Received December 30, 1998

    Report

    Report Number
    2184002-1998-00878
    Event Type
    Injury
    Date Received
    December 30, 1998
    Date of Event
    October 10, 1996
    Report Date
    December 29, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 04/09/1996. IT FAILED AND WAS REMOVED 10/10/1996 DUE TO MOBILITY. THE IMPLANTS HAVE NOT BEEN RETURNED FOR IDENTIFICATION. NO MEDICAL HISTORY HAS BEEN REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUSTAIN 4X13 HA CYLINDER IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. 410010-40-13 75950227

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention