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

Model Number SD980.016

Device Problem No Apparent Adverse Event (3189)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/05/2023

Event Type  Injury  

Event Description

Hardware was removed from the patient due to his allergy to metal.

Manufacturer Narrative

Investigation ongoing.

Event Description

Hardware was removed from the patient due to his allergy to metal.

Manufacturer Narrative

The investigation concluded that the devices met specifications and did not malfunction.The event is attributed to the patient's allergy.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI
• Manufacturer (Section D): MATERIALISE USA, LLC; 44650 helm court; plymouth MI 48170
• Manufacturer (Section G): MATERIALISE USA, LLC; 44650 helm court; plymouth MI 48170
• Manufacturer Contact: jenny jones ; 44650 helm court; plymouth, MI 48170
• MDR Report Key: 18373693
• MDR Text Key: 331114392
• Report Number: 3005718816-2023-00004
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060380167
• UDI-Public: 05420060380167
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: MU23OHOXIF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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: 31 YR
• Patient Sex: Male