BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2080739 · Received May 6, 2011

    Report

    Report Number
    1030489-2011-00527
    Event Type
    Injury
    Date Received
    May 6, 2011
    Report Date
    April 14, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 876-015, 510K # K970806 WAS CLEARED IN THE UNITED STATES. LATERAL (SAGITTAL) T2 AND STIR IMAGINES OF C2/3, C3/4, C4/5 WITH SEVERE CERVICAL STENOSIS AND MYELOMALACIA BEHIND. C3/4 POST OP SHOWS ACDF WITH BONE GRAFT AND PLATE C2-C3-C4 WITH GOOD DECOMPRESSION. FINAL LATERAL CT SHOWS C3 SCREWS FRACTURED WITH STABLE ASTHRODESIS C3 SCREWS BACK OUT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL PROCEDURE AT C3-C5. TWO SCREWS WERE BROKEN AT C3 POST OP. IT WAS REPORTED THAT THE FUSION WAS COMPLETED. A REVISION SURGERY TO REMOVE THE IMPLANTS WAS PERFORMED APPROXIMATELY SIX YEARS POST IMPLANTATION. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM KWQ WARSAW ORTHOPEDIC, INC. NA W05D1671

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Required Intervention PLATE