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

Model Number	SD980.001
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Markings/Labelling Problem (2911); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion is not yet available.Final report will be provided to fda.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MIDFACE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 9144512
• Report Number: 3003998208-2019-00026
• Device Sequence Number: 2622582
• Product Code: JEY
• UDI-Device Identifier: 05420060380013
• UDI-Public: 05420060380013
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 09/04/2019

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: SD980.001
• Device Catalogue Number: SD980.001
• Device Lot Number: ME19ZUTVAC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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: Required Intervention
• Patient Age: 45 YR