BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 8873037 · Received August 8, 2019

    Report

    Report Number
    1030489-2019-00878
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 10, 2019
    Report Date
    August 8, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE, CATALOG # 7753500, 510K # K082728, UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 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 POSTERIOR FIXATION SURGERY AT T2-T3 DUE TO CANCER METASTASIZED TO THE SPINE AND INTERNAL FIXATION TO TREAT DESTRUCTION TO THE VERTEBRAL BODY. INTRA-OP, SET SCREW WAS BROKEN. THE SET SCREWS WERE THREADED FROM THE ROOT AND IT WAS UNABLE TO PLACE CROSSLINK AND AFTER THAT UNABLE TO REMOVE THE SET SCREWS. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667407 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0714260W

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR