BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3122839 · Received May 21, 2013

    Report

    Report Number
    1030489-2013-01815
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CERVICAL PLATE WAS REMOVED FROM A PATIENT BECAUSE THE PATIENT HAD NOT FUSED. IT WAS REPORTED THAT THE INITIAL ACDF TOOK PLACE APPROXIMATELY A YEAR AGO USING A CERVICAL PLATE SYSTEM WITH A 19MM PLATE AND AN UNKNOWN INTERBODY DEVICE. ACCORDING TO THE REPORT, NO MALFUNCTION OF THE CERVICAL PLATE SYSTEM WAS OBSERVED HOWEVER THE INTERBODY DEVICE WAS REPORTEDLY RESORBED. A NEW PLATE (25MM) WAS USED AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224235 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention COMPETITOR INTERBODY DEVICE, SCREWS