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	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
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 having difficulty fitting the fossa component.The fit check guide fit nicely, but he felt the polyethylene was too bulky posteriorly.There was a delay in surgery.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: h6.The reported event could be confirmed based on the report of the sales rep who was present in the surgery.However, no images or scans were provided.During placement of an oversized unilateral tmj implant in (b)(6) 2025, the surgeon encountered difficulty fitting the fossa component, likely due to soft tissue interference, and trimmed the component intraoperatively.The patient is recovering well, but no postoperative imaging is available.Without imaging, the root cause cannot be determined; possible factors include implant positioning, incomplete removal of ankylotic bone, or atypically thick tragal cartilage.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, 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: 23144438
• Report Number: 0002031049-2025-00079
• Device Sequence Number: 18595182
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: CHG024
• Device Lot Number: 2502171038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 03/06/2026
• 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