BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMF CUSTOMIZED IMPLANT KIT X-LARGE

    MDR report key: 3203193 · Received July 2, 2013

    Report

    Report Number
    0002249697-2013-02211
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KKY
    PMA / PMN Number
    K103010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING AN INCORRECT IMPLANT BEING SHIPPED/PRODUCT SWAP INVOLVING A CMF CUSTOMIZED IMPLANT KIT X-LARGE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE HISTORY REVIEW INDICATED THAT THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATES THERE HAVE BEEN NO PREVIOUSLY REPORTED SIMILAR EVENT FOR THE LOT REFERENCED. THE INVESTIGATION CONCLUDED THAT THERE WAS A PRODUCT SWAP RESULTING FROM AN OPERATOR ERROR DURING THE PROCESSING OF THE ORDER FOR SHIPMENT. A MANUFACTURING NONCONFORMANCE WAS INITIATED IN (B)(4) 2013 AND CLOSED IN (B)(4) 2013 FOR THE IDENTIFIED PRODUCT SWAP NONCONFORMANCE. (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY BEFORE IMPLANTATION, IT WAS NOTICED THAT AN INCORRECT CUSTOMIZED IMPLANT WAS SHIPPED TO THE HOSPITAL. THE SURGEON BURRED THE CUSTOMIZED IMPLANT TO FIT TO THE PATIENTS ANATOMY AND USED IT IN CONJUNCTION WITH MESH TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO KNOW ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    DURING SURGERY BEFORE IMPLANTATION, IT WAS NOTICED THAT AN INCORRECT CUSTOMIZED IMPLANT WAS SHIPPED TO THE HOSPITAL. THE SURGEON BURRED THE CUSTOMIZED IMPLANT TO FIT TO THE PATIENTS ANATOMY AND USED IT IN CONJUNCTION WITH MESH TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO KNOW ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302128 CMF CUSTOMIZED IMPLANT KIT X-LARGE IMPLANT KKY STRYKER ORTHOPAEDICS-MAHWAH K08744RL10JAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other