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

Model Number SD980.001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

Investigation ongoing; rc unknown.

Event Description

Patient complained of acute swelling on right cheek.He was admitted for antibiotics and eua.The right plate was removed and placed back with larger screws.Just before operation the patient complained that his left side is also becoming sore.The same operation will likely be done also on the left side.

Event Description

Patient complained of acute swelling on right cheek.He was admitted for antibiotics and eua.The right plate was removed and placed back with larger screws.Just before operation the patient complainted that his left side is also becoming sore.The same operation will likely be done also on the left side.

Manufacturer Narrative

Investigation concluded that the devices met specifications and did not malfunction.No clear root cause could be established for swelling.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI
• 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: 16396086
• MDR Text Key: 309755531
• Report Number: 3003998208-2023-00005
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• 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: ME22LIGHIN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: 29 YR
• Patient Sex: Male