BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKSTONE 12 PRIMARY SCREW

    MDR report key: 289094 · Received August 7, 2000

    Report

    Report Number
    1225457-2000-00002
    Event Type
    Malfunction
    Date Received
    August 7, 2000
    Date of Event
    February 14, 2000
    Report Date
    August 7, 2000
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANTERIOR CERVICAL PLATE 44MM (1) CEPHLAD SCREW FRACTURE. FUSION APPEARS TO BE ACHIEVED, SURGEON INTENDS TO REMOVE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKSTONE 12 PRIMARY SCREW IMPLANT BONE SCREW KWQ BLACKSTONE MEDICAL, INC. 50-1120 007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention