BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSTAIN 3.75X10 HA SCREW

    MDR report key: 166959 · Received May 12, 1998

    Report

    Report Number
    2184002-1998-00351
    Event Type
    Injury
    Date Received
    May 12, 1998
    Date of Event
    January 12, 1998
    Report Date
    May 12, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 11/4/1997. IT FAILED DUE TO INFECTION AND MOBILITY AND WAS REMOVED 1/12/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUSTAIN 3.75X10 HA SCREW Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. 410040-38-10 75971814

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention