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

Catalog Number	CHG024
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
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 placement of the fossa component was problematic.The mandible fractured during manual cutting by the surgeon, leading to inadequate fit of the fossa component.

• Brand Name: TMJ UNILATERAL IMPLANT, OVERSIZED
• 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: 24323475
• Report Number: 0002031049-2026-00006
• Device Sequence Number: 9542003
• Product Code: LZD
• UDI-Device Identifier: 07613327626605
• UDI-Public: 07613327626605
• Combination Product (Y/N): N
• 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): 09/14/2026

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: CHG024
• Device Lot Number: 2503261005
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2025
• 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: Other
• Patient Sex: Unknown