BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKSTONE 16MM BONE SCREW

    MDR report key: 297910 · Received September 21, 2000

    Report

    Report Number
    1225457-2000-00008
    Event Type
    Malfunction
    Date Received
    September 21, 2000
    Date of Event
    February 14, 2000
    Report Date
    September 19, 2000
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    X-RAY TAKEN 02/14/2000 REVEALED TWO BROKEN 16MM BONE SCREWS AT C-7 LEVEL. FUSION APPEARS TO HAVE BEEN ACHIEVED. THE SURGEON DOES NOT INTEND TO REMOVE THE BROKEN SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKSTONE 16MM BONE SCREW IMPLANT SECURING DEVICE KWQ BLACKSTONE MEDICAL, INC. 50-1160 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN