BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3241176 · Received July 22, 2013

    Report

    Report Number
    1030489-2013-03076
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    K130640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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. 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 PATIENT ORIGINALLY UNDERWENT A 1 LEVEL ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) ON AN UNKNOWN DATE USING A CERVICAL PLATE SYSTEM. IT IS REPORTED THAT AN ELECTIVE REVISION, C4 CORPECTOMY AND C3-C5 FUSION, WAS PERFORMED BECAUSE FURTHER DEGENERATIVE CHANGES WERE EVIDENT AT ADJACENT LEVELS AND THE PATIENT FAILED TO FUSE. ACCORDING TO THE REPORT, THE PATIENT HAD "POOR BONE QUALITY" SECONDARY TO OBESITY. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341801 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