BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1854139 · Received September 3, 2010

    Report

    Report Number
    1030489-2010-01129
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    KWQ
    PMA / PMN Number
    K042922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OPTICAL EXAMINATION NOTED ONE IS SIDE BENT SLIGHTLY UPWARD, NO FLATNESS SPECIFICATION IS NOTED ON -04 LOCKING RING PRINT, LIKELY DUE TO COMPRESSION OF LOCKING CAP. DIMENSIONAL ANALYSIS OF LOCKING RING OUTER DIAMETER, MATERIAL THICKNESS, AND GAP DIMENSION ALL FOUND TO BE WITHIN PRINT SPECIFICATION. NO DAMAGE TO LOCKING RING SURFACE IS IDENTIFIED. A REVIEW OF DEVICE HISTORY RECORDS IS NOT POSSIBLE AT THIS TIME WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A FOUR LEVEL ACDF C4-T1 WITH POSTERIOR CERVICAL FUSION AT C4-T3, THE LOCKING RING ON THE ANTERIOR FIXATION PLATE BROKE. THE DTS GUIDE WAS USED DURING THE PROCEDURE. THE 4.0 X 15 VARIABLE ANGLE SELF TAPPING SCREW THAT WAS USED HAD A GOOD PURCHASE. THE NITINOL LOCK RING OF THE PLATE CAME OUT FROM UNDER THE BLUE LOCKING CAP, BUT THE CAP REMAINED. THE SURGEON ATTEMPTED TO REMOVE THE LOCKING CAP, BUT IT HELD FIRMLY IN PLACE. THE CONSTRUCT WAS LEFT IN PLACE WITHOUT THE LOCKING RING DUE TO THE GOOD SCREW PURCHASE AND THE ADDITIONAL FIXATION FROM THE POSTERIOR INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM CERVICAL PLATE KWQ WARSAW ORTHOPEDIC INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR BONE SCREWS