BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3636914 · Received February 20, 2014

    Report

    Report Number
    1030489-2014-00535
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7750444, 510K # K090714 WAS CLEARED IN THE UNITED STATES. THE DEVICE WAS NOT RETURNED FOR EVALUATION HOWEVER FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: AP VIEW OF COMPLEX CONSTRUCT EXTENDING FROM THE UPPER CERVICAL SPINE TO MID THORAX C2-T7. SUBSEQUENT FILM IS ALSO AN AP SHOWING DISENGAGEMENT OF THE VERTEX SYSTEM AND THE THORACIC SYSTEM AT THE LATERAL CONNECTOR ON ONE SIDE. THERE IS SOME DISPLACEMENT OF THE ROD SUGGESTING SOME LOSS OF CORRECTION. SURGICAL STAPLES ARE STILL IN PLACE SUGGESTING A VERY IMMEDIATE POSTOPERATIVE COMPLICATION.

    Additional Manufacturer Narrative · 1

    IMPLANT RETURNED WITHOUT ASSOCIATED RODS OR SET SCREW SUB-COMPONENTS. UNABLE TO PROVIDE ADDITIONAL ANALYSIS WITHOUT EITHER OF THE ATTACHEMENT COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT C2-T7. IT WAS FOUND POST-OP THAT THE CRANIAL RODS DISENGAGED FROM THE DOMINOES ON BOTH SIDES. A REVISION WAS PERFORMED 8 DAYS POST-OP TO RECONNECT THE RODS WITH NEW DOMINOES. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107109 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0169405W

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention RODS, SCREWS