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

Model Number SD980.016

Device Problems Device Appears to Trigger Rejection (1524); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

Device was designed and manufactured according to specifications.There was no change in the cleaning or sterilisation process.Additional investigation is still ongoing.

Event Description

The patient underwent a bi-sagittal split osteotomy of the mandible.Post-operative an infection was reported on one side.

Manufacturer Narrative

After concluding the investigation, a most likely root cause was identified concerning the proximity of the planned screws of the plates to the superior border of the mandible.

Event Description

The patient underwent a bi-sagittal split osteotomy of the mandible.Post-operative an infection was reported on one side.

Manufacturer Narrative

Device was designed and manufactured according to specifications.There was no change in the cleaning or sterilisation process.Different design parameters have been investigated and are not considered as a possible root cause at this time.Manufacturing parameters have been investigated and are not considered as a possible root cause at this time.Additional investigation is still ongoing.

• Brand Name: TRUMATCH
• Type of Device: MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, 3001 ; BE 3001
• MDR Report Key: 8607130
• MDR Text Key: 144939249
• Report Number: 3003998208-2019-00022
• 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,Followup
• Report Date: 06/17/2019

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 Model Number: SD980.016
• Device Catalogue Number: SD980.016
• Device Lot Number: ME18PIXROT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 05/13/2019; 11/27/2019
• Supplement Dates FDA Received: 06/17/2019; 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other