BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2192733 · Received August 5, 2011

    Report

    Report Number
    1030489-2011-01007
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. WE DO NOT BELIEVE THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR SPINAL FUSION AT C5-C7 USING INTERBODY FUSION DEVICE AND ANTERIOR FIXATION PLATE. AFTER THE PATIENT EMERGED FROM ANESTHESIA POST OP, PARALYTIC SYMPTOMS WERE OBSERVED. THE PATIENT UNDERWENT A REVISION SURGERY IMMEDIATELY, THE DAMAGES OF DURA MATER WAS CONFIRMED. THE REVISION SURGERY WAS DISCONTINUED, AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO BE TREATED. DURING THE SECOND REVISION SURGERY, THE SURGEON REMOVED ALL IMPLANTS; DISSECTED C5 AND C6 VERTEBRAL BODIES; AND FUSED C4-C7 USING A LONGER PLATE AND THE AUTOGENOUS BONE GRAFT. HOWEVER, NO IMPROVEMENT IN PATIENT'S PARALYTIC SYMPTOMS WAS OBSERVED AFTER THE SECOND REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWQ WARSAW ORTHOPEDIC, INC. NA 0047178W

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R CAGE