MAUDE Adverse Event Report: MATERIALISE NV PROPLAN CMF; TEMPLATE

Model Number SD900.106

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

Patient Problem Occlusion (1984)

Event Date 03/04/2014

Event Type  Injury  

Event Description

Patient came back for postop clinical exam after orthognathic surgery involving the device and dr.(b)(6) noticed that the midline and bite seemed off.The patient will undergo revision surgery to correct the bite.

Manufacturer Narrative

Investigation of the device design shows the delivered device transfers the surgical plan correctly to the patient.Surgeon indicated he had difficulty moving th mandible into the device (orthognathic splint) because the mandible was not sufficiently mobile, so the device was not used as intended due to a surgical reason externally to the splint.Both the surgeon and the sales consultant checked the occlusion and saw no issues with the device.

• Brand Name: PROPLAN CMF
• Type of Device: TEMPLATE
• Manufacturer (Section D): MATERIALISE NV; leuven ; BE
• Manufacturer (Section G): MATERIALISE USA, LLC; 44650 helm court; plymouth MI 48170
• Manufacturer Contact: technologielaan 12; leuven 3001 ; 6396279
• MDR Report Key: 3830083
• MDR Text Key: 15103640
• Report Number: 3005718816-2014-00001
• Device Sequence Number: 1
• Product Code: HWT
• 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: 03/31/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2014
• Device Model Number: SD900.106
• Device Lot Number: MU14-REX-SEK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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): Required Intervention