Reporting TMD Device Problems to the FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical products. If you suspect problems associated with the use of temporomandibular disorders (TMD) devices, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

To help us learn as much as possible about the adverse events associated with TMD devices, please include the following information in your report, if available:

• Date(s) of device use
• Identification of device used
• Description of the problem including diagnosis, time of onset, and follow up treatment. 
• Description of medical or surgical interventions, including prior interventions, taken, if any
• Pertinent medical history, including metal allergies, diabetes, arthritis, or other chronic illness