BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 1402991 · Received June 11, 2009

    Report

    Report Number
    1030489-2009-00500
    Event Type
    Death
    Date Received
    June 11, 2009
    Report Date
    April 28, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY BOAKYE ET AL IN A PUBLICATION ENTITLED "ANTERIOR CERVICAL DISCECTOMY AND FUSION INVOLVING A POLYETHERETHERKETONE SPACER AND BONE MORPHOGENETIC PROTEIN" (J. NEUROSURG: SPINE 2: 521-525, 2005) THAT A PT UNDERWENT AN ACDF PROCEDURE USING A CERVICAL PLATING SYSTEM, A PEEK INTERBODY DEVICE, AND RHBMP-2/ACS. THE PT DIED FOUR WEEKS POSTOPERATIVELY OF MEDICAL COMPLICATIONS INCLUDING SEPSIS AND RESPIRATORY DISTRESS. THIS PT PRESENTED INITIALLY WITH QUADRIPARESIS FOLLOWING A MOTOR VEHICLE ACCIDENT. HE SUFFERED SPINAL CORD INJURY AND SEVERE MULTISYSTEM INJURIES AS WELL AS LONG BONE FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE KWQ WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ATLANTIS CERVICAL PLATE| PEEK INTERBODY DEVICE| INFUSE BONE GRAFT SMALL KIT