BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3052172 · Received April 11, 2013

    Report

    Report Number
    1030489-2013-00990
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    June 28, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    K063100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL EXAMINATION CONFIRMS IMPLANT ASSEMBLY SEPARATED. OPTICAL EXAMINATION OF THE IMPLANT REVEALS MULTIPLE WITNESS MARKS AND PLASTIC DEFORMATION NOTED IN MULTIPLE LOCATIONS INCLUDING: THE INTERMEDIATE COMPONENT SLIDES AND ON BOTH ANTERIOR AND POSTERIOR SURFACE AREAS AROUND RATCHETING INTERFACE FEATURES, AT THE BOTTOM OF THE RATCHET SPRING POCKET AND THE TOP OUTSIDE EDGE OF THE RATCHET SPRING POCKET. MICROSCOPIC EXAMINATION REVEALS ACP IMPLANT END COMPONENT RATCHETING CATCH FEATURES AND RATCHET SPRING POCKET SIDEWALL PLASTICALLY DEFORMED, SUGGESTING TENSILE OVERLOAD. BONE SCREW WITNESS MARK NOTED AT THE BASE OF THE PLATE SCREW BOSS HOLE CONSISTENT WITH OFF-CENTER OR HYPER-ANGULATED BONE SCREW. TESTING DETERMINED THAT HYPER ANGULATED OR OFF-CENTER SCREW INSERTION COULD RESULT IN LOADS CAPABLE OF DISASSEMBLING THE PLATE. (B)(4). THE ABOVE OBSERVATIONS ARE CONSISTENT WITH TENSILE OVERLOAD. RADIOLOGY FILMS INTERPRETATION: "LATERAL X-RAY OF ACDF C3-C4-C5-C6 WITH VARIOUS SPACERS AND FORMATION OF MINIMAL ADJACENT LEVEL DISEASE. ANATOMIC PEEK AT C3/4 AND C5/6 WITH A [CERVICAL FUSION SPACER] AT C4/5 AND [CERVICAL PLATE] WITH SELF TAPPING SCREWS. THIS IS DATED (B)(6) 2013 AND IS AFTER REVISION. AP AND LATERAL X-RAYS OF CERVICAL SPINE DATED (B)(6) 2011 SHOWS ACDF AT C4-C5-C6 WITH A [CERVICAL PLATE]. SPACERS SHOW SOLID FUSION AT C4/5, INCOMPLETE AT C5/6. ADJACENT LEVEL SPURS AND ARTHRITIS AT C3/4. PLATE APPEARS INTACT IN THESE VIEWS SUPPORTING DAMAGE DURING REVISION, OR BETWEEN DATE OF THESE FILMS AND REVISION."

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON A PREVIOUS ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) FOR A PATIENT IN WHICH THE 40MM PLATE WAS REMOVED. ACCORDING TO THE REPORT, WHEN THE PLATE WAS REMOVED "IT SLID APART INTO TWO PIECES". NO FRAGMENTS REMAINED IN THE PATIENT AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156249 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS 6190040 0014232W

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR ANATOMIC PEEK SPACER