BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUMATCH MIDFACE/MANDIBLE TI 3D PRINTED PL/ MAND/ MINI

    MDR report key: 6593568 · Received May 26, 2017

    Report

    Report Number
    3000270450-2017-10180
    Event Type
    Injury
    Date Received
    May 26, 2017
    Date of Event
    April 29, 2017
    Report Date
    April 29, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH AND WEIGHT ARE UNKNOWN. (B)(4). DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PATIENT CODE (B)(6) USED TO CAPTURE THE NEED TO MAKE ADJUSTMENTS TO THE PATIENT SPECIFIC DEVICES SO THAT THE PATIENT WOULD NOT HAVE A POSTERIOR OPEN BITE. PART SD980.001, LOT ME16TUHQUL: MANUFACTURING LOCATION: CH BELGIUM PLANTABROAD. SUPPLIER: MATERIALISE N.V. MANUFACTURING DATE: APRIL 19, 2017. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NO LONGER EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A PRODUCT INVESTIGATION WAS COMPLETED: COMPLAINED ISSUE COULD NOT BE REPLICATED AND/OR CONFIRMED BASED ON THE AVAILABLE INFORMATION. NO PICTURES AND/OR X-RAYS WERE PROVIDED AND NO MATERIAL WAS RETURNED FOR INVESTIGATION. DEVICE HISTORY RECORD (DHR) REVIEWS WERE PERFORMED FOR THE AFFECTED LOTS, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. NO NON-CONFORMANCE REPORTS WERE MARKED IN THE DHR DURING PRODUCTION. PLANNING, GUIDE DESIGN AND PRODUCTION STEPS THAT COULD EXPLAIN A POSTERIOR OPEN BITE. THEREFORE, IT IS DETERMINED THAT THE MATERIALISE DEVICES PERFORMED AS INTENDED. IN THE PLANNING REPORT SENT TO THE SURGEON, AN OVERLAP OF 0.8 MM WAS INDICATED IN THE POSTERIOR MAXILLARY REGION. SUCH MEASUREMENTS IN THE PLANNING REPORT INDICATE APPROXIMATE OVERLAPS AND POTENTIAL BONY REDUCTIONS NEEDED IN THE POSTERIOR MAXILLA THAT ARE NOT GUIDED WITH THE TITANIUM 3D PRINTED GUIDE FOR MIDFACE. AS THESE BONY REDUCTIONS ARE DONE FREEHAND BY THE SURGEON, IT IS POSSIBLE THAT THE SURGEON REMOVED TOO MUCH BONE OF THE MAXILLA IN THIS REGION. THIS COULD POTENTIALLY HAVE LED TO A SLIGHT DISCREPANCY IN FINAL POSITION OF THE MAXILLA COMPARED TO THE SURGICAL PLAN. A SHALLOW FINAL SPLINT WAS DESIGNED FOR THIS CASE AS PER THE SURGEON¿S REQUEST. POTENTIALLY, THE SURGEON DID NOT FULLY LOCK THE TEETH OF THE MANDIBLE IN THE TEETH IMPRESSIONS OF THE SHALLOW SPLINT POSTERIORLY. COMBINED WITH THE POTENTIAL DISCREPANCY IN MAXILLARY POSITION, THIS COULD HAVE LED TO A POSTERIOR OPEN BITE AS INDICATED BY THE COMPLAINANT. THIS HOWEVER, CANNOT BE CONFIRMED BASED ON THE AVAILABLE INFORMATION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD A BILATERAL POSTERIOR OPEN BITE TWO TO THREE (2-3) MILLIMETERS. THIS OCCURRED WHEN DOING THE MANDIBLE MOVEMENT COMPONENT OF THE SURGERY; IT WAS AFTER PLATING THE MANDIBLE USING THE FINAL SPLINT, AS POSITIONING GUIDE, AND USING THE MANDIBLE PATIENT SPECIFIC PLATES. THE SURGEON ATTEMPTED TO CORRECT THIS VIA SEVERAL STEPS. HE MOVED THE MANDIBLE PLATES AND RE-PLATED; THE PATIENT STILL HAD A BILATERAL POSTERIOR OPEN-BITE. HE TOOK THE SPLINT OUT AND RE-PLATED; THE PATIENT STILL HAD A BILATERAL POSTERIOR OPEN-BITE. HE TOOK THE SPLINT OUT AND REMOVED CUT THE BOTTOM BAR OFF DOUBLE BARS ON PATIENT SPECIFIC MANDIBLE PLATES; THIS IS THE STEP THAT STOPPED THE POSTERIOR OPEN BITE. THERE WAS A SURGICAL DELAY TO PROCEDURE OF NINETY (90) MINUTES. THERE WAS NO ADVERSE EVENT TO PATIENT REPORTED. THIS IS REPORT 2 OF 3 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375826 TRUMATCH MIDFACE/MANDIBLE TI 3D PRINTED PL/ MAND/ MINI BONE PLATE JEY SYNTHES SELZACH ME16-TUH-QUL_I3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention