BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKSTONE SFS ROD

    MDR report key: 758130 · Received October 20, 2005

    Report

    Report Number
    1225457-2005-00012
    Event Type
    Malfunction
    Date Received
    October 20, 2005
    Date of Event
    September 16, 2005
    Report Date
    October 20, 2005
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE ROD BROKE AT THE ROD/SCREW INTERFACE AND IN TWO DISTINCT PLACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKSTONE SFS ROD 600MM ROD KWQ BLACKSTONE MEDICAL, INC. 57-2160 2034 ED10

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization