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

Model Number	SD980.016
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2019
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
Manufacturer narrative: no additional investigation was required as there was no issue with the case (additional information received 31 may 2019) surgeon confirmed that wrong information regarding case identification was initially received.This case had no issue, was not associated with infection.Therefore this correction, follow-up report is send.There is no adverse event or product problem.Outcome attributed to adverse event: there is no outcome since there is no adverse event.Serious injury is not applicable but as 'other' can't be selected and this field has to be completed according to esubmitter this was completed as was done in the initial report.
Event or Problem Description
The patient underwent a bi-sagittal split osteotomy of the mandible.On 31 may 2019, the surgeon confirmed initial feedback was incorrect.No infection associated with the case and also no other problem.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED GUIDE FOR MANDIBLE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, 3001 ; BE 3001
• MDR Report Key: 8607117
• Report Number: 3003998208-2019-00021
• Device Sequence Number: 2339702
• 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
• Report Date (Section B): 05/14/2019

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: No Information
• Device Model Number: SD980.016
• Device Catalogue Number: ME18TADNIP
• Device Lot Number: ME18TADNIP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 07/05/2019
• 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