BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKSTONE ANTERIOR CERVICAL PLATE

    MDR report key: 292470 · Received August 22, 2000

    Report

    Report Number
    1225457-2000-00004
    Event Type
    Malfunction
    Date Received
    August 22, 2000
    Date of Event
    April 20, 2000
    Report Date
    August 14, 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

    55 YR. OLD HX OF CERVICAL STENOSIS CERVICAL SPONDYLOSIS & CERVICAL MYELORADCULOPATHY OPERATED IN 98 ANTERIOR CERVICAL PLATE 46MM SIZE. X-RAYS ON 4/20/00 SHOW SOME BACKING OUT OF C7 LOCKING UNIT. PT. COMPLAINTS OF NUMBNESS BILATERALLY IN LITTLE AND RING FINGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKSTONE ANTERIOR CERVICAL PLATE TOP LOCKING PLATE KWQ BLACKSTONE MEDICAL, INC. 50-3500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR