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

Model Number SD980.001

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Markings/Labelling Problem (2911); Patient Device Interaction Problem (4001)

Patient Problem No Code Available (3191)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

Conclusion is not yet available.Final report will be provided to fda.

Event Description

Correct guide but incorrect maxilla plate was provided to the surgeon and therefore could not be used.The surgical procedure needed to be changed during surgery.Revision surgery may be needed.

Manufacturer Narrative

Narrative: a case was provided which included a patient specific maxilla plate and a patient specific maxilla guide.The maxilla guide performed as intended, and there were no reported issues while using the maxilla guide.The maxilla plate had a case identifier marked directly on the product for the patient, while the design of the plate was based on the pre-surgical plan for another case.Surgery was already ongoing, while this was detected.Type of reportable event should be serious injury and malfunction.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MIDFACE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 9144512
• MDR Text Key: 166226938
• Report Number: 3003998208-2019-00026
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060380013
• UDI-Public: 05420060380013
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD980.001
• Device Catalogue Number: SD980.001
• Device Lot Number: ME19ZUTVAC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR