BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKSTONE 14MM PRIMARY BONE SCREW

    MDR report key: 385280 · Received March 25, 2002

    Report

    Report Number
    1225457-2002-00020
    Event Type
    Malfunction
    Date Received
    March 25, 2002
    Date of Event
    February 19, 2002
    Report Date
    March 25, 2002
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWUP X-RAYS REVEALED A BROKEN 14MM BONE SCREW AT LEVEL C-6. THE PATIENT WENT ON TO FUSE WITHOUT EVENT. THE SURGEON DOES NOT PLAN TO REMOVE IMPLANT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKSTONE 14MM PRIMARY BONE SCREW IMPLANT SECURING DEVICE KWQ BLACKSTONE MEDICAL, INC. 50-1140 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR