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

Model Number SD980.001

Device Problems Difficult or Delayed Positioning (1157); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Device not yet explanted.

Event Description

After the surgery, it was found that the occlusion was off and that this resulted in the patient having an over bite.Surgeon is discussing with patient whether to have a revision surgery or not.

Manufacturer Narrative

Investigation concluded that the bad occlusion was caused by a user error by the surgeon, who did not follow the instructions.The surgeon did not place a graft which was planned to be placed.This caused the maxilla to move when forces were applied.Splint and guides were discarded by surgeon, plates still in patient only fields that have additional information have been completed, all other fields are kept empty as they were reported in the initial report and still correct.

Event Description

After the surgery, it was found that the occlusion was off and that this resulted in the patient having an over bite.Surgeon did coronoidectomy in week 45 and will do revision surgery when patient returns to town in 6 months.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH ORTHOGNATHICS - FULL BIMAXILLARY SURGICAL KIT
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 10788165
• MDR Text Key: 214654057
• Report Number: 3003998208-2020-00012
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• 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: MU20POZFOQ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR