BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICASE CONNECT, SURGICASE GUIDE

    MDR report key: 2864401 · Received December 6, 2012

    Report

    Report Number
    3003998208-2012-00014
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MATERIALISE N.V.
    Product Code
    PBF
    PMA / PMN Number
    K112389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SURGERY WAS ATTENDED BY A PRODUCT ENGINEER WHO PROVIDED EXTRA MEASUREMENTS TO ALLOW EXTRA VERIFICATION OF THE GUIDE FIT. THESE WERE NOT USED BY THE OPERATING SURGEON WHEN POSITIONING THE GUIDE ON THE RADIUS. BASED ON THE AVAILABLE INFORMATION, THE CONCLUSION OF THE INVESTIGATION SHOWS THAT FAILURE TO FOLLOW INSTRUCTIONS HAS CAUSED THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DIAPHYSEAL OSTEOTOMY UTILIZING THE SURGICASE GUIDE TO PREDRILL HOLES FOR THE PLATE AND TO CUT THE WEDGE FOR THE OSTEOTOMY. DIFFICULTY WITH POSITIONING OF THE GUIDE RESULTED IN 2 FAILED ATTEMPTS TO DRILL THE HOLES FOR THE PLATE IN THE RIGHT POSITION. THE 3RD ATTEMPT WAS SUCCESSFUL AND THE PLATE WAS POSITIONED IN THE PLANNED POSITION ON THE RADIUS. THE SURGERY ON THE ULNA WAS PERFORMED WITHOUT ANY PROBLEMS. THE 2 FAILED ATTEMPTS RESULTED IN A DELAY DURING SURGERY OF APPROXIMATELY 35 MIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening