BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARDIS PEEK IMPLANT 09X09X22

    MDR report key: 4092828 · Received August 20, 2014

    Report

    Report Number
    2184052-2014-00170
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    MAX
    PMA / PMN Number
    K073202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING AND IS BASED ON INFORMATION SUBMITTED BY OTHER THAT MAY OR MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO A DEATH OR INJURY.

    Description of Event or Problem · 1

    SAME CASE AS: 2184052-2014-00169. IT WAS REPORTED THE ARDIS IMPLANT BROKE DURING SURGERY. WHEN THE SURGEON ATTEMPTED TO IMPLANT THE ARDIS IMPLANT, IT FRACTURED. THE SURGEON USED ANOTHER IMPLANT OF THE SAME SIZE AND THE SAME INSERTER TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500654 ARDIS PEEK IMPLANT 09X09X22 ARDIS PEEK IMPLANT 09X09X22 MAX ZIMMER SPINE 3201-090922 2314811

    Patients

    Seq Age Sex Outcome Treatment
    1