BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 2437801 · Received February 3, 2012

    Report

    Report Number
    1030489-2012-00119
    Event Type
    Injury
    Date Received
    February 3, 2012
    Report Date
    January 6, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. OPTICAL EXAMINATION CONFIRMED ANTI-MIGRATION FEATURE OF ANTERIOR CERVICAL PLATE IS BROKEN, WITH THE BROKEN OFF PORTION RETURNED FOR ANALYSIS. THE OPPOSITE SIDE IS ALSO CRACKED; THE DIRECTION OF MATERIAL MOVEMENT IS CONSISTENT WITH SCREW BACK-OUT. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED QUASI-BRITTLE FRACTURE, WITH RIVERLINES INDICATING THE DIRECTION OF FRACTURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8799022, 510K # K994239 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON CONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL SURGICAL PROCEDURE AT C5-6 TO TREAT CERVICAL MYELOPATHY. IT WAS REPORTED THAT THE WASHER BROKE ON THE PLATE AT C6 ALLOWING THE SCREWS TO BACK OUT. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE SCREWS AND PLATE 2 YEARS POST-OP. FUSION WAS COMPLETE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0097879W

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS