BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3983273 · Received August 6, 2014

    Report

    Report Number
    1030489-2014-03398
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWQ
    PMA / PMN Number
    K021461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A STUDY CONTROL PATIENT UNDERWENT AN EXTRAPHARYNGEAL ANTEROLATERAL PROCEDURE AT LEVELS C5-C6 <(>&<)> C6-C7. DURING THE 84 MONTH POST-OP VISIT, THE PATIENT REPORTEDLY "PERHAPS HAS DEVELOPED SOME SLIGHT INTERVAL INCREASE IN SUBOCCIPITAL HEADACHE AND AXIAL NECK PAIN WHICH MAY BE RELATED TO THE PREVIOUSLY IDENTIFIED PSEUDOARTHROSIS AT C6-7. X-RAYS APPEAR AGAIN TO SHOW NON-UNION AT C6-7 (ONLY). THERE HAS BEEN NO MIGRATION OF IMPLANTS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459324 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Other SCREWS (X6), ALLOGRAFT (X2)