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

Catalog Number	CHG024
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Fungal Infection (2419)
Date of Event	06/04/2025
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 has been reported that a patient's mandibular implant was removed for a dehiscence with possible fungal infection.From what the rep knows so far, the dehiscence was able to be closed without issue once the implant was removed.
Additional Manufacturer Narrative
Additional information: d4, d6a, d6b, h4, h6 the reported event could not be confirmed as no scans were provided, and the implant was not sent back.The mandibular component was removed due to dehiscence caused by a fungal infection of the soft tissue.This infection developed after the tissue was stretched beyond its capacity to remain viable over the device.Removal was necessary to prevent the infection¿s biofilm from spreading to the mandibular and fossa components and to allow proper closure of the soft tissue.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.
Event or Problem Description
No new information.

• Brand Name: TMJ UNILATERAL IMPLANT, OVERSIZED
• 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: 22357450
• Report Number: 0002031049-2025-00059
• Device Sequence Number: 7997493
• Product Code: LZD
• UDI-Device Identifier: 07613327626605
• UDI-Public: 07613327626605
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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?: No
• Device Expiration Date: 08/04/2026
• Device Catalogue Number: CHG024
• Device Lot Number: 2406111011
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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