BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLAN CMF GUIDES

    MDR report key: 2481127 · Received March 2, 2012

    Report

    Report Number
    3003998208-2012-00007
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    November 21, 2011
    Report Date
    December 21, 2011
    Manufacturer
    MATERIALISE NV
    Product Code
    JEY
    PMA / PMN Number
    K103136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL AND REVIEW OF PROCEDURES UTILIZED DURING THE DATA HANDLING AND SURGERY PLANNING OF THE DEVICE DETERMINED THE EVENT REPORTED WAS DUE TO INACCURATE REPRESENTATION OF CT DATA FROM SECONDARY REFORMATTED OBLIQUE CT IMAGES, WHICH ARE -WITH THE EXCEPTION OF THIS CASE- NEVER USED FOR PLANNING. PLANNING AND GUIDES WERE APPROVED BY THE SURGEON.

    Description of Event or Problem · 1

    SURGERY: MANDIBULAR TUMOR RESECTION. PT'S CT DATA USED FOR DEVICE DESIGN WAS SCALED RESULTING IN A SURGICAL PLAN AND DEVICE THAT DID NOT MATCH THE PT'S ANATOMY ACCURATELY. USED RESECTION GUIDES DID NOT CAUSE DEVIATIONS/PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPLAN CMF GUIDES JEY MATERIALISE NV SD900.001 MU11CORULU

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR