MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH CMF; TRUMATCH ORTHOGNATHIC - BASIC BIMAXILLARY SURGICAL KIT

Model Number	SD980.003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation ongoing; rc unknown.
Event or Problem Description
When the patient was released from (b)(6), the mandible and the occlusion sagged back so the patient ended up with a bigger over jet than we planned, and premature contact caused open bite.
Additional Manufacturer Narrative
The investigation concluded that the device did not malfunction and there was no deterioration in the characteristics of the performance of the device.
Event or Problem Description
When the patient was released from imf, the mandible and the occlusion sagged back so the patient ended up with a bigger over jet than we planned, and premature contact caused open bite.
Additional Manufacturer Narrative
Section d1 - brand name corrected to correspond the one in the label, section d2a - common device name correted to correspond the one in the label, d4 - serial number has been deleted as it is not present in the label - udi related data quality updates only.
Event or Problem Description
When the patient was released from imf, the mandible and the occlusion sagged back so the patient ended up with a bigger over jet than we planned, and premature contact caused open bite.

• Brand Name: TRUMATCH CMF
• Common Device Name: TRUMATCH ORTHOGNATHIC - BASIC BIMAXILLARY SURGICAL KIT
• 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: 17929850
• Report Number: 3003998208-2023-00018
• Device Sequence Number: 12371057
• Product Code: JEY
• UDI-Device Identifier: 05420060380037
• UDI-Public: 05420060380037
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2023

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: SD980.003
• Device Catalogue Number: SD980.003
• Device Lot Number: ME23CEHAZU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 09/14/2023; 02/07/2025
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 02/10/2025; 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR
• Patient Sex: Female