BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3174810 · Received June 18, 2013

    Report

    Report Number
    1030489-2013-02345
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8792111, 510K # K994239 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIAGNOSED WITH "SUBLUXATION" UNDERWENT AN ACDF PROCEDURE AT C6-C7. IT WAS REPORTED THAT 27 DAYS POST-OP, "THE SCREW BACKED OUT". ACCORDING TO THE REPORT, THE "PATIENT WAS UNDER OBSERVATION TO DETERMINE WHETHER SCREW REPLACEMENT NEEDED OR NOT". NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277082 ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CERVICAL PLATE