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

Model Number SD980.014

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Physical Asymmetry (4573)

Event Date 04/22/2020

Event Type  Injury  

Manufacturer Narrative

Investigation concluded that the devices met specifications and did not malfunction.No root cause could be established for the bad bite.

Event Description

Surgeon must remove old lefort plate to place new lf plate to further correct the bite.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MIDFACE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer (Section G): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer Contact: jenny jones ; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 17390019
• MDR Text Key: 319827151
• Report Number: 3003998208-2023-00014
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060380143
• UDI-Public: 05420060380143
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SD980.014
• Device Catalogue Number: SD980.014
• Device Lot Number: MU20ULULOC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male