BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKSTONE ANTERIOR CERVICAL PLATE

    MDR report key: 292996 · Received August 24, 2000

    Report

    Report Number
    1225457-2000-00005
    Event Type
    Malfunction
    Date Received
    August 24, 2000
    Date of Event
    June 28, 2000
    Report Date
    August 23, 2000
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANTERIOR CERVICAL PLATE IMPLANT SCREW BREAK NOTED 6 WEEK POST-OPERATIVE ON FOLLOW-UP X-RAY. REPORTED BY SURGEON. NO REPORTED SYMPTOMS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKSTONE ANTERIOR CERVICAL PLATE SCREW KWQ BLACKSTONE MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN