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

Model Number SD900.105

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/14/2022

Event Type  Injury  

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 Description

Intermediate splint did not lead to desired mandible position.Surgery had to be stopped and completed the following day.

• Brand Name: TRUMATCH
• Type of Device: 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
• MDR Text Key: 295311131
• Report Number: 3005718816-2022-00003
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 05420060351150
• UDI-Public: 05420060351150
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/14/2022

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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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; Hospitalization
• Patient Age: 19 YR
• Patient Sex: Female