BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMATCH

    MDR report key: 9144512 · Received October 2, 2019

    Report

    Report Number
    3003998208-2019-00026
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    September 4, 2019
    Report Date
    September 4, 2019
    Manufacturer
    MATERIALISE NV
    Product Code
    JEY
    UDI-DI
    05420060380013
    PMA / PMN Number
    K170272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NARRATIVE: A CASE WAS PROVIDED WHICH INCLUDED A PATIENT SPECIFIC MAXILLA PLATE AND A PATIENT SPECIFIC MAXILLA GUIDE. THE MAXILLA GUIDE PERFORMED AS INTENDED, AND THERE WERE NO REPORTED ISSUES WHILE USING THE MAXILLA GUIDE. THE MAXILLA PLATE HAD A CASE IDENTIFIER MARKED DIRECTLY ON THE PRODUCT FOR THE PATIENT, WHILE THE DESIGN OF THE PLATE WAS BASED ON THE PRE-SURGICAL PLAN FOR ANOTHER CASE. SURGERY WAS ALREADY ONGOING, WHILE THIS WAS DETECTED. TYPE OF REPORTABLE EVENT SHOULD BE SERIOUS INJURY AND MALFUNCTION.

    Additional Manufacturer Narrative · 1

    CONCLUSION IS NOT YET AVAILABLE. FINAL REPORT WILL BE PROVIDED TO FDA.

    Description of Event or Problem · 1

    CORRECT GUIDE BUT INCORRECT MAXILLA PLATE WAS PROVIDED TO THE SURGEON AND THEREFORE COULD NOT BE USED. THE SURGICAL PROCEDURE NEEDED TO BE CHANGED DURING SURGERY. REVISION SURGERY MAY BE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938056 TRUMATCH TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MIDFACE  JEY MATERIALISE NV SD980.001 ME19ZUTVAC 05420060380013

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention