BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSTAIN 4X10 SCREW IMPLANT

    MDR report key: 202642 · Received December 18, 1998

    Report

    Report Number
    2184002-1998-00869
    Event Type
    Injury
    Date Received
    December 18, 1998
    Date of Event
    August 13, 1998
    Report Date
    December 17, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS PLACED 5/14/1998, SITE #10. IMPLANT WAS REMOVED 8/13/1998 DUE TO INFECTION. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUSTAIN 4X10 SCREW IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. 410040-40-10 75981339

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention