MAUDE Adverse Event Report: MATERIALISE NV PROPLAN CMF; SPLINT, ORTHOGNATHIC, FINAL (CLEAR ACRYLIC)

Model Number	SD900.106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
When placing in the final splint, it became apparent that the final occlusion was not as planned, midline was off by 2mm.Surgeon will be looking at the patient post surgery which will most likely lead to a need of revision surgery.
Additional Manufacturer Narrative
Investigation ongoing; rc unknown.
Additional Manufacturer Narrative
The investigation concluded that the devices did not malfunction and there was no deterioration in the characteristics of the performance, and as such the devices met specifications.The exact reason for reported issue could not be established.
Event or Problem Description
When placing in the final splint, it became apparent that the final occlusion was not as planned, midline was off by 2mm.Surgeon will be looking at the patient post surgery which will most likely lead to a need of revision surgery.

• Brand Name: PROPLAN CMF
• Common Device Name: SPLINT, ORTHOGNATHIC, FINAL (CLEAR ACRYLIC)
• 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: 20817700
• Report Number: 3003998208-2024-00022
• Device Sequence Number: 12683387
• Product Code: HWT
• UDI-Device Identifier: 05420060351167
• UDI-Public: 05420060351167
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 11/08/2024

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: SD900.106
• Device Catalogue Number: SD900.106
• Device Lot Number: ME24RUSHUG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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: 23 YR
• Patient Sex: Male