BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2232518 · Received September 2, 2011

    Report

    Report Number
    1030489-2011-01127
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    July 16, 2011
    Report Date
    August 4, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    K970806
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED ON A USER FACILITY REPORT THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY C4-C5, C5-C6, C6-C7. IT WAS NOTED THAT THE PATIENT PRESENTED TO THE SURGEON WITH RIGHT LOWER EXTREMITY NUMBNESS AND TINGLING. EVALUATION AND WORKUP REVEALED INCOMPLETE BONE FUSION FROM PRIOR SURGERY. APPROXIMATELY 90 MONTHS POST-OP THE PATIENT WAS TAKEN TO OR FOR REMOVAL OF ENTIRE C4-C7 ANTERIOR PLATE CONSTRUCT AND INSERTION OF NEW ANTERIOR CERVICAL PLATE CONSTRUCT AT C4-C5; NEW ANTERIOR CERVICAL PLATE CONSTRUCT AT C6-C7. THE SURGEON DOCUMENTED PROTRUDING HERNIATING BROKEN C4 SCREW AND BILATERAL BROKEN SCREW HEAD, C4 BODY CONSTRUCT. THE PATIENT TOLERATED PROCEDURE WELL AND WAS TRANSFERRED TO THE SURGICAL UNIT AND WAS DISCHARGED 5 DAYS LATER. NO ADDITIONAL PATIENT COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention PLATE