BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 6864250 · Received September 14, 2017

    Report

    Report Number
    1030489-2017-02042
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    August 17, 2017
    Report Date
    August 17, 2017
    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

    THIS PART IS NOT APPROVED FOR SALE IN THE UNITED STATES BUT A SIMILAR PART WITH CATALOGUE # 7750087, 510K # K070742 AND (B)(4) IS APPROVED FOR SALE IN THE US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT OCCIPITAL CERVICAL VERTEBRA POSTERIOR FUSION AT LEVELS O/C3. POST-OP, IT WAS REPORTED THAT THE ROD PLACED ON THE ADJUSTABLE PLATE ON THE LEFT SIDE WAS DEVIATED. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE DEVIATED ROD WAS REMOVED AND REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646235 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0521818W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention