BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2112554 · Received June 3, 2011

    Report

    Report Number
    1030489-2011-00664
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    February 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    K970806
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW WAS RETURNED FOR EVALUATION. BONE SCREW/LOCKING CAP INTERFACE WITNESS MARKS NOT IDENTIFIED ON TOP OF SCREW HEAD. WITNESS MARKS NOTED ON THE SIDE OF SCREW, WITH CORRESPONDING MARKS AND PLASTIC DEFORMATION NOTED ON THE LOCKING CAP BONE SCREW INTERFACE, CONSISTENT WITH BONE SCREW NOT FULLY SEATING BELOW THE LOCKING CAP, WHICH MAY HAVE ALLOWED THE SCREW TO BACK OUT POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION HOWEVER FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND TWO LATERAL X-RAYS OF PLATE AT C3- C4-C5-C6 WITH VERTEBRAL BODY REPLACEMENTS. ONE FILM IS TAKEN WITH FLUOROSCOPY INTEROPERATIVELY. THE SECOND FILMS SHOWS BACK OUT OF ONE OF THE C6 SCREWS. BOTH FILMS SHOW THE PLATE 3-4 MM PROUD (VENTRAL) TO C6 BODY AND NOT SEATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A THREE LEVEL ANTERIOR CERVICAL FUSION. DURING ROUTINE FOLLOW UP IT WAS FOUND THAT THE BONE SCREW HAD BACKED OUT OF THE PLATE. THE PATIENT UNDERWENT REVISION SURGERY TO HAVE THE BONE SCREW REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    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 H10C6565

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention PLATE