BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE PLANNER, SIGNATURE GUIDES

    MDR report key: 3862745 · Received May 23, 2014

    Report

    Report Number
    3003998208-2014-00006
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MATERIALISE N.V.
    Product Code
    JWH
    PMA / PMN Number
    K102795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION IS IN PROGRESS WHICH HAS NOT YET RESULTED IN A ROOT CAUSE FOR THE EVENT. AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED AS SOON AS THE INVESTIGATION IS TERMINATED.

    Description of Event or Problem · 1

    THE PT UNDERWENT A TOTAL KNEE REPLACEMENT GUIDED BY THE DEVICE. THE FEMORAL IMPLANT WAS IMPLANTED WITH A RECURVATUM AND SO THERE WAS A NOTCH ON THE ANTERIOR CORTICAL. THE INITIAL PLANNING DIDN'T PROPOSE RECURVATUM, IT PROPOSED A FLEXION OF 1.5 DEGREES. THERE WAS NO PT INJURY/HARM, NO BLOOD LOSS, NO SURGICAL DELAY REPORTED. NO INTERVENTION OR ADDITIONAL SURGERY ARE PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309049 SIGNATURE PLANNER, SIGNATURE GUIDES KNEE PROSTHESIS JWH MATERIALISE N.V. 42-422461 102301

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability