BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2112576 · Received June 3, 2011

    Report

    Report Number
    1030489-2011-00665
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Report Date
    June 13, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K063100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLATE WAS RETURNED FOR EVALUATION. VISUALLY CONFIRMED LOCKING CAP BROKEN OFF OF PLATE; RETURNED LOCKING CAP BREAKAGE APPEARS CONSISTENT WITH SAMPLE OVER TIGHTENED LOCKING CAPS. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER FILMS WERE SUPPLIED FOR REVIEW. 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. WHILE UNLOCKING THE LOCKING MECHANISM ON THE PLATE THE PLATE FELL APART. THE PLATE WAS REMOVED AND REPLACED ALONG WITH THE BONE SCREWS. 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 KWP WARSAW ORTHOPEDIC, INC. NA W08J3471

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW