MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI

Model Number	SD980.016
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was designed and manufactured according to specifications.There was no change in the cleaning or sterilisation process.Additional investigation is still ongoing.
Event or Problem Description
The patient underwent a bi-sagittal split osteotomy of the mandible.Post-operative an infection was reported on one side.
Additional Manufacturer Narrative
After concluding the investigation, a most likely root cause was identified concerning the proximity of the planned screws of the plates to the superior border of the mandible.
Event or Problem Description
The patient underwent a bi-sagittal split osteotomy of the mandible.Post-operative an infection was reported on one side.
Additional Manufacturer Narrative
Device was designed and manufactured according to specifications.There was no change in the cleaning or sterilisation process.Different design parameters have been investigated and are not considered as a possible root cause at this time.Manufacturing parameters have been investigated and are not considered as a possible root cause at this time.Additional investigation is still ongoing.

• Brand Name: TRUMATCH
• Common Device Name: MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, 3001 ; BE 3001
• MDR Report Key: 8607130
• Report Number: 3003998208-2019-00022
• Device Sequence Number: 19403387
• Product Code: JEY
• UDI-Device Identifier: 05420060380174
• UDI-Public: 05420060380174
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SD980.016
• Device Catalogue Number: SD980.016
• Device Lot Number: ME18PIXROT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019; 11/27/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/17/2019; 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other