BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKSTONE 12MM PRIMARY SCREWS

    MDR report key: 286792 · Received July 18, 2000

    Report

    Report Number
    1225457-2000-00001
    Event Type
    Malfunction
    Date Received
    July 18, 2000
    Date of Event
    January 21, 2000
    Report Date
    July 18, 2000
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANTERIOR CERVICAL PLATE IMPLANTED IN 1999. X-RAYS REVEAL ON 1/21/00 TWO SUPERIOR SCREWS BROKE, TOP LOCKING PLATE HOLDS IN PLACE. NO INJURY ALLEGED, FUSION APPEARS TO HAVE TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKSTONE 12MM PRIMARY SCREWS IMPLANT BONE SCREWS KWQ BLACKSTONE MEDICAL, INC. 50-1120 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention