BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2024170 · Received March 18, 2011

    Report

    Report Number
    1030489-2011-00306
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    May 10, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K063100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUALLY CONFIRMED LOCKING CAP HEAD BROKEN OFF FROM THE THREADED PLATE INTERFACE PORTION OF THE CAP. OPTICAL EXAMINATION REVEALS WITNESS MARK AT THE BASE OF LOCKING CAP HEAD, AND NO WITNESS MARKS NOTED ON THE BONE SCREW INTERFACE PORTION OF THE LOCKING CAP HEAD. OPTICAL EXAMINATION OF THE FRACTURE SURFACE REVEALS A FAIRLY BRITTLE FRACTURE SURFACE WITH NO INDICATION OF FATIGUE AND RIVER LINES INDICATIVE OF OVERLOAD. SAMPLE TESTING WAS ABLE TO THE REPLICATE THE FAILURE MODE BY OVERTIGHTENING THE LOCKING CAP. A COMPARISON OF THE PLATE WITNESS MARKS AND LOCKING CAP FOUND SIMILARITIES BETWEEN THE REPLICATED FAILURE AND THE RETURNED IMPLANT.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL SPINAL FUSION. IT WAS REPORTED THAT THE LOCKING RING BROKE OFF OF THE PLATE. THE PLATE AND SCREWS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWP WARSAW ORTHOPEDIC, INC. NA 0024907W

    Patients

    Seq Age Sex Outcome Treatment
    1