BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGNATURE PLANNER; SIGNATURE GUIDES

    MDR report key: 3190954 · Received June 21, 2013

    Report

    Report Number
    3005718816-2013-00007
    Event Type
    Other
    Date Received
    June 21, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MATERIALISE NV
    Product Code
    JWH
    PMA / PMN Number
    K102795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. 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

    A TOTAL KNEE REPLACEMENT SURGERY WAS PERFORMED ON THE PATIENT GUIDED BY THE DEVICE. THE PHYSICIAN REPORTED THE PATIENT SPECIFIC INSTRUMENTS DID NOT REGISTER ON THE BONE OF THE PATIENT. THE PHYSICIAN USED TRADITIONAL INSTRUMENTATION TO CONTINUE AND FINISH THE PROCEDURE. THIS CAUSED A DELAY OF APPROXIMATELY 30 MINUTES. NO OTHER INJURY OR SIGNIFICANT BLOOD LOSS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283959 SIGNATURE PLANNER; SIGNATURE GUIDES JWH MATERIALISE NV 42-422566 74479

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other