BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKSTONE TOP LOCKING PLATE

    MDR report key: 296693 · Received September 14, 2000

    Report

    Report Number
    1225457-2000-00007
    Event Type
    Malfunction
    Date Received
    September 14, 2000
    Date of Event
    August 11, 2000
    Report Date
    September 11, 2000
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT RETURNED TO THE HOSP 9 DAYS AFTER A 74MM ANTERIOR CERVICAL PLATE WAS IMPLANTED IN 2000. PT FILE STATES THAT PT SUFFERED A C-7 BURST FRACTURE (GRAFT COLLAPSED). DR EXPLANTED THE 74MM PLATE AND SECURING HARDWARE. REPORT ALSO STATES THAT THE TOP LOCKING PLATE HAD COME OFF. A BLACKSTONE PLATE WAS NOT RE-IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention