BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSTAIN 4.2X13 MC EXTERNAL HEX HA IMPLANT

    MDR report key: 187789 · Received September 18, 1998

    Report

    Report Number
    2184002-1998-00653
    Event Type
    Injury
    Date Received
    September 18, 1998
    Date of Event
    February 23, 1998
    Report Date
    September 18, 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 WAS PLACED 02/03/1998. IT WAS REMOVED 02/23/1998 DUE TO MOBILITY. A LARGE DIAMETER (4.7MM) IMPLANT WAS THEN PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUSTAIN 4.2X13 MC EXTERNAL HEX HA IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. 410050-42-13 75980219

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention