BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VSP SYSTEM

    MDR report key: 11037135 · Received December 18, 2020

    Report

    Report Number
    1724955-2020-00006
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    November 19, 2020
    Report Date
    December 17, 2020
    Manufacturer
    3D SYSTEMS
    Product Code
    DZJ
    UDI-DI
    00816847020633
    PMA / PMN Number
    K192192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STRYKER FACIAL ID PLATING SYSTEM (K193143) CUSTOMIZED PLATES DID NOT ALIGN WITH 3D SYSTEMS GUIDES (LEFORT MARKING GUIDE, MAXILLA CUTTING GUIDE, AND SAGITTAL SPLIT MARKING GUIDE). THIS ISSUE WAS IDENTIFIED DURING SURGERY AFTER THE SURGEON HAD USED THE GUIDES TO FIXATE CUSTOM PLATES IN THE PATIENT'S MAXILLA AND MANDIBLE. UPON IDENTIFICATION, THE PLATES WERE REMOVED AND NEW HOLES WERE DRILLED FOR FIXATION. THE ISSUE CAUSED UNNECESSARY HOLES TO BE DRILLED INTO THE PATIENT , HOWEVER, THE SURGERY WAS SUCCESSFUL WITH NO ADVERSE EFFECTS TO THE PATIENT. THE ISSUE ADDED 90 ADDITIONAL MINUTES TO THE PROCEDURE. INVESTIGATION IDENTIFIED CASE PLANNING FILES WERE INCORRECTLY EXPORTED BY 3D SYSTEMS PERSONNEL RESULTING IN THE 3D SYSTEMS GUIDES TO INCORRECTLY INDICATE THE CUSTOM PLATE FIXATION HOLE LOCATION FOR THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504730 VSP SYSTEM SURGICAL GUIDE DZJ 3D SYSTEMS Sagittal Split Marking Guide 141324 00816847020633

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other