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

Model Number	SD980.014
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Difficulty Chewing (4522)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation concluded device met specification.An assessment of the patient post-op scan concluded that the issue was caused by a significant deviation in the osteotomy performed during the surgical procedure, leading to the bone positions.
Event or Problem Description
The surgeon stated that actual movements obtained intra-operatively differed vastly from the movements planned pre-operatively.A revision surgery will be performed to correct the position of the jaws.
Event or Problem Description
The surgeon stated that actual movements obtained intra-operatively differed vastly from the movements planned pre-operatively.A revision surgery will be performed to correct the position of the jaws.
Additional Manufacturer Narrative
Section d4: serial number has been deleted as it is not present in the label; udi related data quality updates only.Section g: type of report changed from "initial" to "follow-up #1".

• 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
• 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: 18375398
• Report Number: 3003998208-2023-00024
• Device Sequence Number: 7579578
• Product Code: JEY
• UDI-Device Identifier: 05420060380143
• UDI-Public: 05420060380143
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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: SD980.014
• Device Catalogue Number: SD980.014
• Device Lot Number: ME23VIZCEB
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2023
• 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: 32 YR
• Patient Sex: Male