MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ BILATERAL IMPLANTS, OVERSIZED; JOINT, TEMPOROMANDIBULAR, IMPLANT

Catalog Number	CHG026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
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 the surgeon was not able to mobilize the mandible enough to get the intermediate splint in place, and the lefort was not completed as they were not sure if they would get the correct result.

• Brand Name: TMJ BILATERAL IMPLANTS, 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 drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23656749
• Report Number: 0002031049-2025-00090
• Device Sequence Number: 4903305
• Product Code: LZD
• UDI-Device Identifier: 07613327626568
• UDI-Public: 07613327626568
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CHG026
• Device Lot Number: 2506031091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• 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