BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3318935 · Received August 30, 2013

    Report

    Report Number
    1030489-2013-03781
    Event Type
    Injury
    Date Received
    August 30, 2013
    Date of Event
    July 31, 2013
    Report Date
    August 1, 2013
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). A LIKE DEVICE IS APPROVED FOR USE IN THE UNITED STATES DEVICE CATALOG # 7750444, 510K # K K121191 WAS CLEARED IN THE UNITED STATES. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    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 THE PATIENT UNDERWENT A FIXATION WAS CONNECTED BETWEEN C7 AND TH1. IT WAS REPORTED THAT WHEN THE PATIENT GOT OUT OF BED POST-OPERATIVELY, THE CONNECTOR WAS DISLODGED AT ONE SIDE. THE SURGEON COMMENTED THAT THE DEVICE COULD NOT SECURE ROD SUFFICIENTLY. A REVISION SURGERY IS SCHEDULED TO REMOVE THE CONNECTOR AND RE-CONNECT THE CONSTRUCT. PATIENT IS EXPERIENCING NUMBNESS IN HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429525 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. 0169405W

    Patients

    Seq Age Sex Outcome Treatment
    1