BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 1996337 · Received February 18, 2011

    Report

    Report Number
    1030489-2011-00152
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8792911, 510K # K030327 WAS CLEARED IN THE UNITED STATES. THREE VIEWS OF CERVICAL PLATE SHOWS BACK OUT OF ONE OF ONE OF CRANIAL SCREWS. FUSION APPEARS SOLID AND PLATE REMOVED WAS ELECTED. DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL SURGICAL PROCEDURE OF AN ANTERIOR FIXATION CONSTRUCT POST FUSION, THE SELF DRILLING SCREW COULD NOT BE EXPLANTED. THE CASE WAS COMPLETED WITHOUT ADDITIONAL COMPILATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHIR ANTERIOR CERVICAL SYSTEM KWP WARSAW ORTHOPEDIC, INC. NA W05A5272

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Other