BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKSTONE PRIMARY SCREW

    MDR report key: 288736 · Received August 3, 2000

    Report

    Report Number
    1225457-2000-00003
    Event Type
    Malfunction
    Date Received
    August 3, 2000
    Date of Event
    February 2, 2000
    Report Date
    August 3, 2000
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT. HAD A TWO LEVEL ANTERIOR CERVICAL PLATE IMPLANT IN 1999. ON 2/2/00 X-RAY SHOWED SCREW BREAK, FUSION HAD TAKEN PLACE. NO REMOVAL OF IMPLANT/SCREW AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN