MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ UNILATERAL IMPLANT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Catalog Number	CHG010
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had to stay in hospital for few days longer than normal as the prosthesis was not fitting 100% due to lack of splints at the surgery phase.Based on a post op ct scan of the patient, the mandibular part is angulated slightly forward.
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
No new information.
Additional Manufacturer Narrative
Additional information: d4, d6a, h6 correction: d2a.The reported malposition could not be confirmed as no post op scans were provided.The absence of the surgical splints during surgery could be confirmed based on the internal communication and tracking of the shipping.It was determined that the tmj surgery was performed without the planned surgical splints due to delivery delays caused by the rescheduled surgery date, late po processing, and shipping address corrections.As a result, the prosthesis was positioned suboptimally and the procedure was prolonged by approximately 30 minutes.The surgeon elected to proceed despite the absence of the splints.The patient was discharged without immediate complications; however, it was later reported that the device was removed due to a recurrent chronic infection.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.

• 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 drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23816125
• Report Number: 0002031049-2025-00124
• Device Sequence Number: 13263638
• Product Code: LZD
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

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?: No
• Device Catalogue Number: CHG010
• Device Lot Number: 2508041030
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 07/22/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown