BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2072785 · Received April 29, 2011

    Report

    Report Number
    1030489-2011-00477
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K042922
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. VISUALLY CONFIRMED LOCKING RING BROKEN IN MULTIPLE LOCATIONS. MICROSCOPIC EXAMINATION OF FRACTURE REVEALS A FAIRLY BRITTLE FRACTURE SURFACE WITH RIVER LINES CONSISTENT WITH OVERLOAD. THE LOCATION AND NATURE OF FRACTURES SUGGEST OVERLOAD DUE TO SCREW BACKOUT RESULTING IN SUBSEQUENT FAILURE. BONE SCREWS AND X-RAYS OF INITIAL CONSTRUCT NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGICAL PROCEDURE. IT WAS REPORTED THAT 15 MONTHS POST-OP THE PATIENT UNDERWENT REVISION SURGERY DUE TO A NON-UNION AT C6-7. DURING THE REVISION, IT WAS FOUND THAT THE LOCKING MECHANISM ON THE PLATE HAD FAILED AND THE SCREWS HAD BACKED OUT SLIGHTLY. THE SCREWS AND PLATE WERE REMOVED AND THE PATIENT WAS RE-INSTRUMENTED WITH NEW HARDWARE. NO ADDITIONAL 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 0018306W

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention SCREWS