MAUDE Adverse Event Report: MATERIALISE USA, LLC TRUMATCH; SPLINT, ORTHOGNATHIC, INTERMEDIATE (CLEAR ACRYLIC)

Model Number	SD900.105
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intermediate splint did not lead to desired mandible position due to an issue with the transfer of the planning to the splint design.
Event or Problem Description
Intermediate splint did not lead to desired mandible position.Surgery had to be stopped and completed the following day.

• Brand Name: TRUMATCH
• Common Device Name: SPLINT, ORTHOGNATHIC, INTERMEDIATE (CLEAR ACRYLIC)
• Manufacturer (Section D): MATERIALISE USA, LLC; 44650 helm court; plymouth MI 48170
• Manufacturer (Section G): MATERIALISE USA, LLC; 44650 helm court; plymouth MI 48170
• Manufacturer Contact: jenny jones ; 44650 helm court; plymouth, MI 48170 ; 0032163966
• MDR Report Key: 14926836
• Report Number: 3005718816-2022-00003
• Device Sequence Number: 6289394
• Product Code: HWT
• UDI-Device Identifier: 05420060351150
• UDI-Public: 05420060351150
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SD900.105
• Device Catalogue Number: SD900.105
• Device Lot Number: MU22AZEPEL
• 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: 06/14/2022
• Initial Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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; Hospitalization
• Patient Age: 19 YR
• Patient Sex: Female