BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 1543756 · Received November 20, 2009

    Report

    Report Number
    1030489-2009-01092
    Event Type
    Injury
    Date Received
    November 20, 2009
    Date of Event
    October 27, 2009
    Report Date
    October 27, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG #8799027, 510K #K994239 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A CERVICAL FUSION AT C3/4. A REVISION SURGERY WAS REPORTEDLY PERFORMED APPROXIMATELY 15 MONTHS POST OP, DUE TO PSEUDOARTHROSIS AND THE BACKED OUT SCREW AT C3 RIGHT SIDE. AT THE REVISION PROCEDURE, IT WAS FOUND THAT THE WASHER AT RIGHT C3 WAS BROKEN. THE BROKEN PIECE WAS NOT FOUND AND COULD NOT BE RETRIEVED. THE PLATE WAS REPLACED. THE SURGEON STATED THAT PSEUDOARTHROSIS MAY HAVE CAUSED STRESS ON IMPLANTS, LEADING TO THE SCREW BACK OUT AND WASHER BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHIR ANTERIOR CERVICAL SYSTEM PLATE KWP WARSAW ORTHOPEDIC INC. NA W06H0888

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention CERVICAL SCREW CATALOG #G8792113, LOT#W07F4178