BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 2864503 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02765
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 11, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # 0180952W AND # 0213872W.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL PROCEDURE AT C1/2 TO TREAT ATLANTOAXIAL SUBLUXATION DUE TO TRAUMA. . IT WAS REPORTED THAT THE PATIENT DEVELOPED PARALYSIS. BONE UNION HAS NOT OCCURRED. THE SURGEON IS PLANNING A REOPERATION FOR REMOVAL OF IMPLANTS. THE SURGEON COMMENTED THAT THE PROCEDURE AND IMPLANTS WERE NO PROBLEM AND THE EVENT WAS CAUSED BY NARROWNESS OF SPINAL CORD MORE THAN USUAL AT IMPLANTED LEVEL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Required Intervention