BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 8706626 · Received June 18, 2019

    Report

    Report Number
    1030489-2019-00637
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    May 20, 2019
    Report Date
    June 18, 2019
    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 USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG#7753807, 510K#K123656, 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 CERVICAL THORACIC POSTERIOR FIXATION AT C4/TH4. POST-OP, TAPERED ROD WAS BROKEN NEAR C7/TH1. IT WAS OBSERVED DURING THE OPERATION. NO ANY FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. THE BROKEN ROD WAS REMOVED. FUSION FOR EXTENDING WAS PERFORMED TO THE CRANIAL SIDE USING CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502787 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention