BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARDIS PEEK IMPLANT 08X09X22

    MDR report key: 1941684 · Received December 10, 2010

    Report

    Report Number
    1649384-2010-00177
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ZIMMER SPINE
    Product Code
    MAX
    PMA / PMN Number
    K073202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L RELEVANT INFO WILL BE PROVIDED WHEN THE DEVICE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ARDIS IMPLANT BROKE DURING THE SURGERY. NO FURTHER INFO IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARDIS PEEK IMPLANT 08X09X22 ARDIS IMPLANT MAX ZIMMER SPINE 3201-080922 2215061

    Patients

    Seq Age Sex Outcome Treatment
    1