BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 6892980 · Received September 26, 2017

    Report

    Report Number
    1030489-2017-02109
    Event Type
    Injury
    Date Received
    September 26, 2017
    Date of Event
    August 28, 2017
    Report Date
    August 28, 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 CATALOG # 7755124, 510K # K082728 AND UDI # (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR DECOMPRESSION FUSION AT LEVELS O/C3 FOR OCCIPITAL CERVICAL VERTEBRA. POST-OP, IT WAS REPORTED THAT THE ROD PLACED ON THE RIGHT SIDE WAS DEVIATED. DURING THE REVISION SURGERY, THIS DEVIATED ROD WAS REMOVED AND REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675011 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0217953W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention