BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2052195 · Received April 12, 2011

    Report

    Report Number
    1030489-2011-00407
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    November 25, 2010
    Report Date
    March 14, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K021461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. H10: PER THE REPORTER, THE REPORTED EVENT IS NOT BELIEVED TO BE RELATED TO THE MALFUNCTION OF THE DEVICE. WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL PLATE FIXATION SURGERY. A 75 MM PLATE WAS IMPLANTED AND THE SURGERY WAS SUCCESSFUL. WHEN THE PATIENT HAD AN X-RAY HALF A MONTH LATER, IT WAS FOUND THAT THE PLATE WAS NOT FIT FOR THE VERTEBRAL. IT WAS THOUGHT THE PLATE WAS TOO LONG FOR THE PATIENT. THE SECONDARY SURGERY WAS PERFORMED. AT THE SECOND PROCEDURE, THE PLATE WAS NOT REMOVED. INSTEAD, TWO SCREWS WERE REMOVED AND FOUR 4.5 MM FIXATION SCREWS WERE ADDED. NO PATIENT COMPLICATIONS WERE REPORTED BEFORE AND AFTER THE SECONDARY SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL PLATE FIXATION SURGERY. A 75 MM PLATE WAS IMPLANTED AND THE SURGERY WAS SUCCESSFUL. WHEN THE PATIENT HAD AN X-RAY HALF A MONTH LATER, IT WAS FOUND THAT THE PLATE WAS NOT FIT FOR THE VERTEBRAL. IT WAS BELIEVED THAT THERE WERE NOT ENOUGH FIXATION SCREWS IMPLANTED AT THE INDEX SURGERY. THE REVISION SURGERY TO REPLACE TWO FIXATION SCREWS AND ADD TWO FIXATION SCREWS IS TO PREVENT THE FUTURE RISK TO THE PATIENT. 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 0085875W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FIXATION BONE SCREWS