MAUDE Adverse Event Report: MATERIALISE NV PROPLAN CMF; SPLINT AND PLANNING KIT, ORTHOGNATHIC KIT, TWO SPLINTS

Model Number	SD900.008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In follow-up meeting with patient, midline was 5mm off center and there was significant yaw.
Additional Manufacturer Narrative
Investigation concluded that the devices met specifications and did not malfunction.No root cause could be established for the significant yaw issue.

• Brand Name: PROPLAN CMF
• Common Device Name: SPLINT AND PLANNING KIT, ORTHOGNATHIC KIT, TWO SPLINTS
• 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: 16931511
• Report Number: 3005718816-2023-00001
• Device Sequence Number: 12496364
• Product Code: HWT
• UDI-Device Identifier: 05420060350573
• UDI-Public: 05420060350573
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/24/2023

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: SD900.008
• Device Catalogue Number: SD900.008
• Device Lot Number: MU23EKOFET
• 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: 04/04/2023
• Initial Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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: Disability
• Patient Age: 42 YR
• Patient Sex: Male