0601 Longitudinal Analysis of FDA MAUDE Reports for Oral Appliances: Recent Shift in Adverse Event Profiles (2020–2025)

Abstract Introduction The US Food and Drug Administration (FDA) monitors post-market safety of oral appliances for the indication of treating obstructive sleep apnea and snoring under product codes LRK, LQZ, and PLC. Historically, adverse events in this category have been infrequent. Yet, there has been a recent introduction of direct-to-consumer (DTC) models without dentist oversight that has altered device distribution. This study utilizes the Manufacturer and User Facility Device Experience (MAUDE) database to quantify reported trends in both report volume and the nature of device failures associated with non-traditional delivery models. Methods A retrospective database analysis was conducted for product codes LRK, LQZ, and PLC from January 2020 through December 2025. Adverse events were categorized into primary failure modes through a manual review of narrative information. Data was stratified by year and 11 event type categories (e.g., allergy, broken device, bite change). Two time cohorts were defined: Period A (2020–2023) and Period B (2024–2025). Chi-square test of independence was performed to evaluate the relationship between the time period and the distribution of adverse event categories. Results A total of 835 reports were identified for code LRK, while codes LQZ and PLC showed negligible activity (n < 5). The mean annual report volume was 41.5 in Period A and 333.5 in Period B. Furthermore, the safety profile demonstrated a fundamental shift. In Period A, allergy was the primary adverse event (74.8% of complaints), with broken device category comprising 8.5%. In Period B, this distribution inverted significantly (Chi-squared test, p < 0.0001): broken device reports rose to 92.3% of classified, while allergy reports decreased proportionately. One type of device accounted for 97.6% (n = 651) of Period B complaints. Conclusion The years 2024–2025 exhibit a statistically significant discontinuity in FDA MAUDE reporting for oral appliance therapy, with one device overrepresented. The data indicates not only an 8-fold increase in report volume but also a fundamental change in failure mode—shifting from biocompatibility issues (allergies) to mechanical integrity failures (device fracture). Further research should investigate the distinct change of high-volume mechanical failure and if this is attributable to the DTC model due to current remote fabrication and delivery processes. Support (if any)