MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TRUMATCH ORTHOGNATHIC - FULL BIMAXILLARY SURGICAL KIT

Model Number	SD980.001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Facial Nerve Paralysis (1846)
Date of Event	10/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is on going.
Event or Problem Description
The surgeon accidentally cut the nerve when completing the left ventral cut on the mandible.This can cause a (temporarily) paralyzed lip, depending on how well the nerve heals in the following weeks/months according to the surgeon.
Additional Manufacturer Narrative
A review of the internal documentation did not show an anomaly or deviation.While a cause for this specific clinical event cannot be ascertained from the information provided, it suggests the nerve cutting was related to the fact that the nerve was located more buccally and therefore was not visible on the cbct images.Should additional information become available that changes this assessment, an amended medical device report will be filed.
Event or Problem Description
The surgeon accidentaly cut the nerve when completing the left ventral cut on the mandible.Patient is doing well.Surgeon said that probably the lip will be permanently paralyzed.However, it is possible that the patient regains some feeling.They will have a second surgery to take out the plates in march where they will reassess the nerve damage with a neurologist.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH ORTHOGNATHIC - FULL BIMAXILLARY SURGICAL KIT
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, 3001 ; BE 3001
• MDR Report Key: 9287120
• Report Number: 3003998208-2019-00028
• Device Sequence Number: 150891
• Product Code: JEY
• UDI-Device Identifier: 05420060380013
• UDI-Public: 05420060380013
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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: SD980.001
• Device Catalogue Number: SD980.001
• Device Lot Number: ME19CORPOP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 02/21/2020
• 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: 30 YR
• Patient Weight: 74