BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARDIS PEEK IMPLANT 08X09X22

    MDR report key: 1872389 · Received October 11, 2010

    Report

    Report Number
    1649384-2010-00167
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ZIMMER SPINE
    Product Code
    MAX
    PMA / PMN Number
    K073202
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. EVAL IS PENDING UPON COMPLETED INVESTIGATION OF THE PRODUCT.

    Description of Event or Problem · 1

    THE PT UNDERWENT A ONE-LEVEL TLIF SURGERY AT L4-L5 ON (B)(6) 2010. AS THE SURGEON PLACED A PEEK IMPLANT INTO THE DISC SPACE USING APPROPRIATE SURGICAL TECHNIQUE, THE END OF THE IMPLANT BROKE OFF WHEN THE SURGEON TAPPED IT TO ADVANCE IT. ALL PIECES OF THAT IMPLANT WERE REMOVED AND THE SURGEON IMPLANTED ANOTHER IMPLANT INTO THE DISC SPACE. AS HE TAPPED THAT IMPLANT, IT CRACKED DOWN THE MIDDLE, HE REMOVED THE CRACKED IMPLANT IN ONE PIECE. THIS DID NOT CAUSE OR CONTRIBUTE TO DEATH, SERIOUS INJURY OR PT HARM. THIS MALFUNCTION HAS BEEN ASSOCIATED WITH AN ADVERSE EVENT IN THE PAST. THE SURGEON WAS ABLE TO PLACE A THIRD IMPLANT INTO THE DISC SPACE WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARDIS PEEK IMPLANT 08X09X22 ARDIS MAX ZIMMER SPINE NA 2222651

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK