BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 3232710 · Received July 18, 2013

    Report

    Report Number
    1030489-2013-03060
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    K030327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL AND OPTICAL EXAMINATION IDENTIFIED DAMAGE AND MATERIAL REMOVAL FROM THE HEAD OF THE SCREW, CONSISTENT WITH EXPLANTATION AS PER THE EVENT DESCRIPTION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ¿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¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334719 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR