BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPLAN CMF

    MDR report key: 3830083 · Received May 1, 2014

    Report

    Report Number
    3005718816-2014-00001
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 31, 2014
    Manufacturer
    MATERIALISE NV
    Product Code
    HWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE DEVICE DESIGN SHOWS THE DELIVERED DEVICE TRANSFERS THE SURGICAL PLAN CORRECTLY TO THE PATIENT. SURGEON INDICATED HE HAD DIFFICULTY MOVING TH MANDIBLE INTO THE DEVICE (ORTHOGNATHIC SPLINT) BECAUSE THE MANDIBLE WAS NOT SUFFICIENTLY MOBILE, SO THE DEVICE WAS NOT USED AS INTENDED DUE TO A SURGICAL REASON EXTERNALLY TO THE SPLINT. BOTH THE SURGEON AND THE SALES CONSULTANT CHECKED THE OCCLUSION AND SAW NO ISSUES WITH THE DEVICE.

    Description of Event or Problem · 1

    PATIENT CAME BACK FOR POSTOP CLINICAL EXAM AFTER ORTHOGNATHIC SURGERY INVOLVING THE DEVICE AND DR. (B)(6) NOTICED THAT THE MIDLINE AND BITE SEEMED OFF. THE PATIENT WILL UNDERGO REVISION SURGERY TO CORRECT THE BITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261586 PROPLAN CMF TEMPLATE HWT MATERIALISE NV SD900.106 MU14-REX-SEK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention