BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR® ANTERIOR CERVICAL SYSTEM

    MDR report key: 3770943 · Received April 24, 2014

    Report

    Report Number
    1030489-2014-02298
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWQ
    PMA / PMN Number
    K073285
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8792815, 510K # K030327 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR CERVICAL DECOMPRESSION AND FUSION AT C3-C4. POSTOPERATIVELY, 2 SCREWS AT THE CRANIAL AND THE CAUDAL SIDES WERE FOUND TO BE BACKED-OUT. A REVISION SURGERY WAS PERFORMED TO EXCHANGE ALL THE IMPLANTS WITH NEW ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249089 ZEPHIR® ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H11B2125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention