BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLACKSTONE SFS SELF-TAPPING MULTI-AXIAL SCREW

    MDR report key: 678300 · Received February 17, 2006

    Report

    Report Number
    1225457-2006-00002
    Event Type
    Injury
    Date Received
    February 17, 2006
    Date of Event
    January 10, 2006
    Report Date
    February 13, 2006
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SCREW BROKE APPROXIMATELY 6 MONTHS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKSTONE SFS SELF-TAPPING MULTI-AXIAL SCREW 7.5MM SELF-TAPPING MULTI-AXIAL SCREW KWQ BLACKSTONE MEDICAL, INC. 58-3XXX B02

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention