MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED GUIDE FOR MANDIBLE

Model Number SD980.017

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

Patient Problems Nerve Damage (1979); Insufficient Information (4580)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

Investigation ongoing.

Event Description

The mandible saggital split cut has damaged the nerve.

Manufacturer Narrative

Device was designed and manufactured according to specification.Root cause could not be established.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED GUIDE FOR MANDIBLE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 11160597
• MDR Text Key: 226526726
• Report Number: 3003998208-2021-00001
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060380174
• UDI-Public: 05420060380174
• Combination Product (y/n): N
• PMA/PMN Number: K170272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD980.017
• Device Catalogue Number: SD980.017
• Device Lot Number: ME20CEQQOL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other