BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGNATURE PLANNER; SIGNATURE GUIDES

    MDR report key: 3205210 · Received June 28, 2013

    Report

    Report Number
    3003998208-2013-00009
    Event Type
    Other
    Date Received
    June 28, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MATERIALISE N.V.
    Product Code
    JWH
    PMA / PMN Number
    K102795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION AND THE DEVICE DID NOT SHOW AN ANOMALY OR DEVIATION. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. THE PRODUCT WAS NOT YET RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TKA PROCEDURE GUIDED BY THE DEVICE, THE PERFORMED FEMORAL CUTS WERE IN VARUS INSTEAD OF THE EXPECTED VALGUS AND THE TIBIAL CUT WAS IN VALGUS INSTEAD OF THE EXPECTED VARUS. AS A RESULT, A DELAY OF APPROXIMATELY 30 MINUTES OCCURRED. NO OTHER INJURY OR SIGNIFICANT BLOOD LOSS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295091 SIGNATURE PLANNER; SIGNATURE GUIDES JWH MATERIALISE N.V. 42-422466 76260

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other