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

Model Number SD900.008

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Physical Asymmetry (4573)

Event Date 02/20/2023

Event Type  Injury  

Event Description

In follow-up meeting with patient, midline was 5mm off center and there was significant yaw.

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
• Type of Device: 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
• MDR Text Key: 315214952
• Report Number: 3005718816-2023-00001
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 05420060350573
• UDI-Public: 05420060350573
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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): Disability
• Patient Age: 42 YR
• Patient Sex: Male