MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ UNILATERAL IMPLANT; Joint, Temporomandibular, Implant

Catalog Number	CHG010
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Unspecified Musculoskeletal problem (4535); Insufficient Information (4580)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
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 discrepancies caused inaccurate surgical cuts and improper fit of the tmj and custom plates, ultimately requiring abandonment of the custom orthognathic portion to ensure stability and accurate joint positioning.

• Brand Name: TMJ UNILATERAL IMPLANT
• 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: 25315526
• Report Number: 0002031049-2026-00076
• Device Sequence Number: 9920220
• Product Code: LZD
• UDI-Device Identifier: 07613327626551
• UDI-Public: 07613327626551
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: CHG010
• Device Lot Number: 2504301041
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• 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