BEUDAMED
    FDA Adverse Event Summary report: N

    ICON MODULAR FIXATION SET SCREW

    MDR report key: 959792 · Received April 26, 2007

    Report

    Report Number
    1225457-2007-00006
    Date Received
    April 26, 2007
    Date of Event
    January 23, 2007
    Report Date
    April 26, 2007
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO PROVIDED.

    Description of Event or Problem · 1

    DR. PERFORMED A TWO LEVEL (L4-S1) SURGERY. TWO WEEK POST OP CONSTRUCT DISASSOCIATED FROM SCREW. REVISION WAS COMPLETED 2007 REPLACING THE ICON SYSTEM WITH THE SFS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON MODULAR FIXATION SET SCREW SET SCREW KWQ BLACKSTONE MEDICAL, INC. 54-2001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention