MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ UNILATERAL IMPLANT; PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Catalog Number	CHG010
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Insufficient Information (4580)
Date of Event	12/08/2025
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 the surgeon was unable to place the fossa component and decided to omit it, packing the joint with fat instead.The mandibular component was successfully implanted.A new fossa component is needed.

• Brand Name: TMJ UNILATERAL IMPLANT
• Common Device Name: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
• 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: 23827575
• Report Number: 0002031049-2025-00125
• Device Sequence Number: 5067645
• Product Code: LZD
• UDI-Device Identifier: 07613327626551
• UDI-Public: 07613327626551
• 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
• Report Date (Section B): 12/17/2025

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: CHG010
• Device Lot Number: 2507301024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown