BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1905173 · Received November 22, 2010

    Report

    Report Number
    1030489-2010-01490
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 12, 2010
    Report Date
    December 1, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K063100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED FOR EVALUATION. THE RATCHET SPRING IS MISSING AND NOT RETURNED FOR ANALYSIS. MACROSCOPIC EXAMINATION CONFIRMS PLATE SEPARATED AT THE RATCHET SPRING INTERFACE. SIGNIFICANT DAMAGE NOTED TO IMPLANT SCREW HOLE BOSS AND MULTIPLE LOCATIONS ON IMPLANT, INCLUDING THE RATCHET SPRING POCKET AREA, CONSISTENT WITH EXPLANTATION. RATCHET SPRING RETENTION POCKET REVEALS WITNESS MARKS CONFIRMING INITIAL PRESENCE OF RATCHET SPRING. OPTICAL EXAMINATION OF IMPLANT DID NOT REVEAL WITNESS MARKS CONSISTENT WITH TENSILE OVERLOAD, POSSIBLY DUE TO THE SIGNIFICANT DAMAGE NOTED TO THE FACE OF THE RATCHET SPRING POCKET AREA. THE RATCHET SPRING CATCH FEATURES DID NOT REVEAL ANY DAMAGE OR WITNESS MARKS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PLATE 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 AN ANTERIOR CERVICAL DISCECTOMY FUSION AT C3-C7. IT WAS REPORTED THAT THE PLATE BROKE WHILE BEING IMPLANTED INTO THE PATIENT. THE PLATE WAS REMOVED AND REPLACED WITH A NEW PLATE. AFTER THE SURGERY THE PATIENT WAS UNABLE TO LIFT THEIR RIGHT ARM.

    Description of Event or Problem · 1

    NI

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDIC, INC. 0028207W

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention BONE SCREW