BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 5562501 · Received April 8, 2016

    Report

    Report Number
    1030489-2016-01037
    Event Type
    Injury
    Date Received
    April 8, 2016
    Report Date
    March 14, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 510(K): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958730PT, 510K # K143471 WAS CLEARED IN THE UNITED STATES. (B)(4). NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016: THE PATIENT WITH ATLANTOAXIAL SUBLUXATION UNDERWENT POSTERIOR FUSION AT C1/2 USING THE MEDICAL DEVICES (SCREWS). AFTER THE OPERATION (DATE UNKNOWN): SCREW AT C1 WAS BACKED OUT AND THE DAMAGE TO VERTEBRAL ARTERY WAS FOUND. ON (B)(6) 2016: RE-FIXATION OF SCREWS WITH MAGERL WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217177 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention