BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 2232616 · Received September 2, 2011

    Report

    Report Number
    1030489-2011-01131
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K082728
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A 4 LEVEL POSTERIOR CERVICAL FUSION. IT WAS REPORTED THAT WHEN MANUALLY TIGHTENING THE LOCKING CAP ON THE CONNECTOR, THE THREADED "POSTED" PORTION OF THE ALREADY TIGHTENED MULTI AXIAL SCREW CONNECTOR SCREW SHEARED OFF FLUSH WITH THE TULIP HEAD. IT WAS DETERMINED THAT THE SCREW WAS EXTREMELY SECURE AND STILL LOCKING DOWN THE ROD SO THE CONSTRUCT WAS LEFT IN PLACE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR CONNECTOR