BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL 2

    MDR report key: 4898765 · Received July 2, 2015

    Report

    Report Number
    3004153240-2015-00124
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 5, 2015
    Manufacturer
    CONFORMIS, INC.
    Product Code
    OIY
    PMA / PMN Number
    K142161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LABELS WERE INCORRECTLY APPLIED TO THE POLY INSERT POUCHES. THE POUCH LABELS DID NOT MATCH THE INSERT SIZE WITHIN THE POUCH. ALL POUCHES WERE LABELED WITH THE CORRECT SERIAL NUMBER. ALL INSERTS PROVIDED WERE THE CORRECT SIZE AND CORRECT SERIAL NUMBER. THE SURGERY WAS COMPLETED SUCCESSFULLY. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. LABEL RETAINS INDICATE THAT THE CORRECT POLY INSERT LABELS WERE PRESENT. IT APPEARS THAT THE LABELS WERE APPLIED TO THE WRONG POUCHES WITHIN THE KIT.

    Description of Event or Problem · 1

    LABELS WERE INCORRECTLY APPLIED TO THE POLY INSERT POUCHES. THE POUCH LABELS DID NOT MATCH THE INSERT SIZE WITHIN THE POUCH. ALL POUCHES WERE LABELED WITH THE CORRECT SERIAL NUMBER. ALL INSERTS PROVIDED WERE THE CORRECT SIZE AND CORRECT SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433145 ITOTAL 2 TOTAL KNEE REPLACEMENT SYSTEM OIY CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR