BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARDIS PEEK IMPLANT 08X09X22

    MDR report key: 2201472 · Received August 3, 2011

    Report

    Report Number
    1649384-2011-00048
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ZIMMER SPINE
    Product Code
    MAX
    PMA / PMN Number
    K073202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE IMPLANT IS NOT POSSIBLE SINCE A PORTION REMAINED IN THE PATIENT AND THE OTHER WAS DISCARDED AT THE HOSPITAL. NO CONCLUSIONS CAN BE MADE FROM THE INFORMATION AVAILABLE. THERE WERE NO INDICATIONS OF MANUFACTURING, PRODUCT, OR SYSTEM DISCREPANCIES OR DEFICIENCIES, THEREFORE THE NEED FOR FURTHER ACTION IS NOT INDICATED. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE PROXIMAL CORNER OF THE IMPLANT BROKE. THE SURGEON RETRIEVED THE BROKEN PIECE AND DISPOSED OF IT. THE REMAINDER OF THE IMPLANT WAS USED IN THE PATIENT. THERE WAS LESS THAN ONE MINUTE DELAY IN THE CASE AND NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARDIS PEEK IMPLANT 08X09X22 ARDIS IMPLANT MAX ZIMMER SPINE 3201-080922 2236522

    Patients

    Seq Age Sex Outcome Treatment
    1