MAUDE Adverse Event Report: TMJ Solutions, LLC dba TMJ Concepts TMJ Bilateral Implants; Joint, Temporomandibular, Implant

Catalog Number	CHG020
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it was questioned whether the increased vertical height was attributable to the fossa components rather than the mandibular component.No adverse consequences, surgical delay, or medical intervention were reported at intake.

• Brand Name: TMJ Bilateral Implants
• Common Device Name: Joint, Temporomandibular, Implant
• Manufacturer (Section D): TMJ Solutions, LLC dba TMJ Concepts; 6059 king drive; ventura 93003
• Manufacturer (Section G): TMJ Solutions, LLC dba TMJ Concepts; 6059 king drive; ventura 93003
• Manufacturer Contact: tanja büchel ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 50929022
• Report Number: 0002031049-2026-00107
• Device Sequence Number: 10725319
• Product Code: LZD
• UDI-Device Identifier: 07613327626575
• UDI-Public: 07613327626575
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CHG020
• Device Lot Number: 2601261049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown