MAUDE Adverse Event Report: TMJ Solutions, LLC dba TMJ Concepts TMJ Unilateral Implant; Joint, Temporomandibular, Implant

Catalog Number	CHG010
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery for a right side non-stryker tmj implant is required due to pain.During the revision planning of the non-stryker tmj implant on the right mandible, the surgeon observed that the contralateral left mandibular prosthesis was close to lateral dislocation due to a loose screw.The left-side implant was not the reason to request the revision surgery, since it does not create any symptoms for the patient and was considered as an incidental finding.

• 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: tanja büchel ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 50864544
• Report Number: 0002031049-2026-00106
• Device Sequence Number: 13434643
• 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
• Type of Report: Initial
• 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: 2207221028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/23/2026
• 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
• Patient Sex: Unknown