BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSTAIN 5X13 HA EXTERNAL HEX IMPLANT

    MDR report key: 184147 · Received August 26, 1998

    Report

    Report Number
    2184002-1998-00549
    Event Type
    Injury
    Date Received
    August 26, 1998
    Date of Event
    December 5, 1997
    Report Date
    August 26, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS PLACED 09/26/1997. IT FAILED AND WAS REMOVED 12/05/1997. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUSTAIN 5X13 HA EXTERNAL HEX IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. 410030-50-13 75960460

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention