BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 1471398 · Received June 11, 2009

    Report

    Report Number
    1030489-2009-00529
    Event Type
    Malfunction
    Date Received
    June 11, 2009
    Date of Event
    May 14, 2009
    Report Date
    May 14, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). 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. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8799142, 510K# K991239 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WHO HAD C4 COMPRESSION FRACTURE UNDERWENT A SPINAL PROCEDURE TO IMPLANT ANTERIOR FIXATION AT C3-C5. IT WAS REPORTED THAT A LOCKING CAP WAS NOT PROPERLY PLACED ON THE SCREW AT C5. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHIR ANTERIOR CERVICAL SYSTEM PLATE KWQ WARSAW ORTHOPEDIC INC. NA W07K4149

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR