MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ BILATERAL IMPLANTS; Joint, Temporomandibular, Implant

Catalog Number	CHG020
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint locking (2672)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Event or Problem Description
It was reported that starting in (b)(6) 2023, the patient reported a sensation of the jaw moving ¿out of alignment,¿ accompanied by bite disturbance, increased pain and episodes of ¿locking¿.

• 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: elena gehring ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 25135156
• Report Number: 0002031049-2026-00066
• Device Sequence Number: 21195797
• Product Code: LZD
• UDI-Device Identifier: 07613327626575
• UDI-Public: 07613327626575
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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 Expiration Date: 12/01/2014
• Device Catalogue Number: CHG020
• Device Lot Number: T13-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown