BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3892940 · Received June 24, 2014

    Report

    Report Number
    1030489-2014-02880
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K082728
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    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 A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE AT C1-C2 FOR INSTABILITY AND A FRACTURE. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE LOCKING SCREW WAS "DEMOLISHED". THE DEVICE BROKE AND ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. PATIENT ACHIEVED SOLID FUSION. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367588 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR