BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 2157562 · Received July 12, 2011

    Report

    Report Number
    1030489-2011-00874
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    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 # 8799145, 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 UNDERWENT A CERVICAL FUSION AT C3/5 AND WAS IMPLANTED ANTERIOR FIXATION PLATE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. THE POST OP X-RAYS SHOWED THE CONSTRUCTION WAS GOOD. THE DAY AFTER THE PROCEDURE THE WHOLE CONSTRUCT BACKED OUT WITH GRAFTED BONE. THE REVISION SURGERY TO REPLACE THE PLATE WITH A NEW PLATE AND RECONSTRUCT WITH REVISION SCREWS WAS PERFORMED FIVE DAYS POST OP. THE REVISION SURGERY WAS COMPLETED WITHOUT ANY INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDIC, INC. 0073607W

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention SCREWS