BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICASE CONNECT, SURGICASE GUIDE

    MDR report key: 2888845 · Received December 21, 2012

    Report

    Report Number
    3003998208-2012-00015
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MATERIALISE NV
    Product Code
    PBF
    PMA / PMN Number
    K112389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE WAS IDENTIFIED AFTER A REVIEW OF THE INTERNAL DOCUMENTATION. DURING THE PREPARATION OF THE REC'D PT IMAGES FOR 3D CONVERSION, THE IMAGES WERE MIRRORED. BECAUSE OF THIS, THE RESULTING 3D MODEL USED TO DESIGN THE GUIDE, WAS ALSO MIRRORED, RESULTING IN A 3D MODEL AND GUIDE APPEARING TO BE DESIGN FOR A LEFT HAND SIDE. THIS WAS NO IDENTIFIED DURING PLAN APPROVAL WITH THE SURGEON OR DURING QUALITY INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A EXTRA-ARTICULAR RADIUS OSTEOTOMY OF THE RIGHT SIDE UTILIZING THE SURGICASE GUIDE TO PREDRILL HOLES FOR THE PLATE AND TO CUT THE WEDGE FOR THE OSTEOTOMY. DURING SURGERY IT BECAME APPARENT THAT THE GUIDE DID NOT FIT THE PT ANATOMY BECAUSE THE INCLUDED MODEL REPRESENTING THE RADIUS REPRESENTED A LEFT SIDE RADIUS. THEREFORE,THE GUIDE COULD NOT BE USED TO DRILL OR CUT. THE SURGEON REVERTED TO TRADITIONAL INSTRUMENTS TO PERFORM THE SURGERY. THERE WAS NO SERIOUS INJURY OF THE PT NOR A SIGNIFICANT INCREASE IN SURGERY TIME REPORTED BECAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICASE CONNECT, SURGICASE GUIDE PBF MATERIALISE NV

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR