MAUDE Adverse Event Report: MATERIALISE USA, LLC TRUMATCH; PATIENT SPECIFIC SPLINT, ORTHOGNATHIC, FINAL

Model Number	SD900.106
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation ongoing: return of device requested but not received.
Event or Problem Description
Palatal splint broke and could not be used, additional treatment to place new splint needed.
Additional Manufacturer Narrative
Breakage of splint related to surgical procedure with multiple piece maxilla with a palatal splint to stabilize the pieces.

• Brand Name: TRUMATCH
• Common Device Name: PATIENT SPECIFIC SPLINT, ORTHOGNATHIC, FINAL
• Manufacturer (Section D): MATERIALISE USA, LLC; 44650 helm court; plymouth MI 48170
• MDR Report Key: 12382006
• Report Number: 3005718816-2021-00002
• Device Sequence Number: 4892043
• Product Code: HWT
• UDI-Device Identifier: 05420060351167
• UDI-Public: 05420060351167
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: SD900.106
• Device Catalogue Number: SD900.106
• Device Lot Number: MU21IKITAQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR