MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS FACIAL ID-ORTHOG-5PLATES; IMPLANT

Catalog Number	78-92005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the plate did not fit.
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 during surgery, the plate did not fit.
Additional Manufacturer Narrative
Update: d6a, h4, h6 correction: b2, g1 the reported event is confirmed based on the analysis of the post-operative scans of the patient.The design team reviewed the upc plates and confirmed that the final plates matched the original planning file and surface, with no deviations found.Based on the investigation, there is no indication of an incorrectly functioning product or any design, material, or manufacturing-related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaints have been added to the complaint trend.
Additional Manufacturer Narrative
The reported event is confirmed based on the analysis of the post-operative scans of the patient.The design team reviewed the upc plates and confirmed that the final plates matched the original planning file and surface, with no deviations found.Based on the investigation, there is no indication of an incorrectly functioning product or any design, material, or manufacturing-related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaints have been added to the complaint trend.
Event or Problem Description
It was reported that during surgery, the plate did not fit.

• Brand Name: FACIAL ID-ORTHOG-5PLATES
• Common Device Name: 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: 20299635
• Report Number: 0008010177-2024-00103
• Device Sequence Number: 21049489
• Product Code: JEY
• UDI-Device Identifier: 07613327370843
• UDI-Public: 07613327370843
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K182305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 78-92005
• Device Lot Number: 2407031050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 09/18/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 03/12/2025; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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: Other; Required Intervention
• Patient Sex: Unknown