BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKSTONE MEDICAL PRIMARY SCREW

    MDR report key: 289085 · Received August 7, 2000

    Report

    Report Number
    1225457-2000-00006
    Event Type
    Malfunction
    Date Received
    August 7, 2000
    Date of Event
    January 24, 2000
    Report Date
    August 7, 2000
    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

    SURGERY IN 1999. ANTERIOR CERVICAL PLATE 42MM (50-5420) 14MM PRIMARY SCREW BREAKAGE SEEN ON X-RAY IN 2000. FUSION REPORTEDLY HAS TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKSTONE MEDICAL PRIMARY SCREW ANTERIOR CERVICAL IMPLANT KWQ BLACKSTONE MEDICAL, INC. 50-1140 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR