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

Model Number	SD980.001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Sinusitis (4844)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation ongoing; rc unknown.
Event or Problem Description
Patient complained of acute swelling on right cheek.He was admitted for antibiotics and eua.The right plate was removed and placed back with larger screws.Just before operation the patient complained that his left side is also becoming sore.The same operation will likely be done also on the left side.
Event or Problem Description
Patient complained of acute swelling on right cheek.He was admitted for antibiotics and eua.The right plate was removed and placed back with larger screws.Just before operation the patient complainted that his left side is also becoming sore.The same operation will likely be done also on the left side.
Additional Manufacturer Narrative
Investigation concluded that the devices met specifications and did not malfunction.No clear root cause could be established for swelling.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI
• 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: 16396086
• Report Number: 3003998208-2023-00005
• Device Sequence Number: 17792635
• Product Code: JEY
• UDI-Device Identifier: 05420060380013
• UDI-Public: 05420060380013
• 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: 2022
• Device Explanted 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): 01/27/2023

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: SD980.001
• Device Catalogue Number: SD980.001
• Device Lot Number: ME22LIGHIN
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: 29 YR
• Patient Sex: Male