BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1060759 · Received June 12, 2008

    Report

    Report Number
    1030489-2008-00274
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    April 7, 2008
    Report Date
    May 14, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    JDN
    PMA / PMN Number
    K970806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLATE AND SCREWS REMAIN IMPLANTED. PRODUCT RETURN IS NOT POSSIBLE AT THIS TIME. THE POST OP X-RAYS WERE REVIEWED. IT WAS CONFIRMED BOTH SCREWS AT C5 BROKE. IT APPEARS THERE WAS EXCESSIVE SUBSIDENCE OF THE GRAFT. THIS CAUSED THE LOAD TO BE SHIFTED TO THE PLATE AND SCREWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TWO-LEVEL ACDF USING ANTERIOR FIXATION. THE PT COMPLAINED OF INCREASED AXIAL NECK PAIN AT THE 6 WEEK POST-OP VISIT. AT THE 3 MONTH POST-OP VISIT, PT REPORTED SYMPTOMS HAD WORSENED. MRI SHOWED NO EVIDENCE OF ADJACENT LEVEL FAILURE AND CT SHOWED GOOD EARLY BONE CONSOLIDATION. AT 6 MONTHS POST OP VISIT (9 MONTHS POST OP), THE X-RAYS SHOWED BROKEN SCREWS AT THE C5. A COLLAR AND BONE STIMULATOR WAS ORDERED FOR THE PT. THERE EXISTS A POSSIBILITY OF REVISION SURGERY IN FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM BONE SCREW JDN WARSAW ORTHOPEDIC INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR