BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2232532 · Received September 2, 2011

    Report

    Report Number
    1030489-2011-01128
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 28, 2011
    Report Date
    September 2, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K042922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. VISUALLY CONFIRMED LOCKING CAP AND RING HAVE BEEN SEPARATED FROM THE PLATE; THE CAP HAS BEEN RETURNED FOR ANALYSIS. MINIMAL SURFACE SCRATCHES NOTED ON ANTERIOR OR POSTERIOR SURFACE,AS WELL AS FOR EITHER SIDE OF LOCK RETAINER CAP POCKET. DIMENSIONAL EVALUATION OF THE RELEVANT LOCKING RING AND LOCKING CAP HOLE RETAINING FEATURES ON THE PLATE DIMENSIONALLY INSPECTED, AND FOUND TO BE WITHIN PRINT SPECIFICATION. ATYPICAL WITNESS MARKS ON THE ANTERIOR SIDE OF THE LOCKING CAP RETAINING TABS ARE NOTED. THE PLATE HOLDING DRILL GUIDE LOCATES WITH A SPRING LOADED COLLET IN THE CENTER OF THE LOCKING CAP. REMOVAL OF THE PLATE WITHOUT DECOMPRESSING THE COLLET CAN OVERCOME THE LOCKING CAP RETAINING FEATURES. BENCH TESTING WITH A SAMPLE DRILL GUIDE AND PLATE WAS ABLE TO INDUCE CAP TAB FAILURE WITH REMOVAL WITHOUT COLLET DECOMPRESSION, HOWEVER A COMPARISON OF THE RETURNED AND SIMULATED LOCKING CAPS IDENTIFIED DIFFERENCES BETWEEN TWO COMPONENTS, SUGGESTING THE DRILL GUIDE WAS APPROPRIATELY UTILIZED WITH RESPECT TO THE PLATE INTERFACE.

    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 AN ANTERIOR CERVICAL DISCECTOMY AND FUSION. IT WAS REPORTED THAT THE LOCKING MECHANISM DI SENGAGED FROM THE PLATE WHILE TRYING TO SIZE THE PLATE USING THE PLATE HOLDING GUIDE. THE LOCKING MECHANISM REMAINED ON THE GUIDE. THE PLATE WAS REMOVED FROM THE PATIENT AND ANOTHER PLATE WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDIC, INC. NA 0006821W

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE