BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMF CUSTOMIZED IMPLANT KIT LARGE

    MDR report key: 5050109 · Received September 2, 2015

    Report

    Report Number
    0002249697-2015-02903
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 10, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KKY
    PMA / PMN Number
    K103010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A SIZE/FIT ISSUE INVOLVING A CMF CUSTOMIZED IMPLANT KIT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS THE SUBJECT DEVICE WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. -DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT A DOCTOR STATED DURING A CASE THAT PART (B)(4) DID NOT FIT THE PATIENT DIMENSIONS CORRECTLY. THE DOCTOR USED A BENDER AND A CUTTER TO MAKE THE PART FIT, AND IT WAS STILL IMPLANTED IN THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT A DOCTOR STATED DURING A CASE THAT PART #54440300 DID NOT FIT THE PATIENT DIMENSIONS CORRECTLY. THE DOCTOR USED A BENDER AND A CUTTER TO MAKE THE PART FIT, AND IT WAS STILL IMPLANTED IN THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583086 CMF CUSTOMIZED IMPLANT KIT LARGE POLYTETRAFLUOROETHYLENE WITH CARBON FIBERS COMPOSITE IMPLANT MATERIAL. KKY STRYKER ORTHOPAEDICS-MAHWAH K10135PM01MAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other