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

Model Number SD980.001

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

Patient Problem Physical Asymmetry (4573)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

Investigation ongoing; determined as reportable on 4 april 2022.Device still implanted.

Event Description

Patient has a retruded mandible with an anterior overbite after surgery.

Manufacturer Narrative

Surgeon did not place bsso guides and plates in the correct position and insufficient bone was removed posteriorly at the maxilla.H3: root cause determined.No return of plates required.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH ORTHOGNATHIC - FULL BIMAXILLARY SURGICAL KIT
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer (Section G): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer Contact: jenny jones ; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 14050016
• MDR Text Key: 288913508
• Report Number: 3003998208-2022-00007
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060380013
• UDI-Public: 05420060380013
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

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: SD980.001
• Device Catalogue Number: SD980.001
• Device Lot Number: ME21TIXHUH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Sex: Female