BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARDIS PEEK IMPLANT 10X09X26

    MDR report key: 2142138 · Received May 26, 2011

    Report

    Report Number
    1649384-2011-00037
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ZIMMER SPINE
    Product Code
    MAX
    PMA / PMN Number
    K073202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE IMPLANT USING MAGNIFICATION REVEALED MARKS AND DEFORMATION OF THE PLASTIC WHERE THE INSERTER MATES AND HOLDS THE IMPLANT SUGGESTING THAT IT WAS BEING ROTATED AT THE TIME IT BROKE CONTRARY TO INSTRUCTIONS PROVIDED IN THE ARDIS SURGICAL TECHNIQUE. THERE WERE NO INDICATIONS OF MANUFACTURING, PRODUCT, LABELING, 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. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, AN ARDIS IMPLANT CRACKED AND BROKE INTO PIECES UPON IMPACTING THE IMPLANT WITH A MALLET. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT AND ANOTHER OF THE SAME SIZE WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARDIS PEEK IMPLANT 10X09X26 ARDIS IMPLANT MAX ZIMMER SPINE 3201-100926 2250511

    Patients

    Seq Age Sex Outcome Treatment
    1