For over a decade, the safety profile of mandibular advancement devices (MADs)—the oral appliances used to treat obstructive sleep apnea (OSA)—was considered a model of consistency. Year after year, the US Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database recorded a modest, stable trickle of adverse event reports. However, a recent analysis of this data has unveiled a startling, tenfold spike in reporting activity throughout 2024 and 2025, prompting a debate among clinicians, manufacturers, and regulators about whether this trend signals a genuine safety crisis or a systemic shift in how medical device data is captured.
The Genesis of the Inquiry
The discovery began not in a high-level government boardroom, but in the routine research of two clinicians preparing for an industry webinar. Dentists Sue Ellen Richardson, DDS, DABDSM, FAASM, and Aaron Glick, DDS, FICOI, FAGD, DABDSM, were curating data to illustrate the safety of oral appliances when they encountered an anomaly in the MAUDE database.
"I was going to point out that the MAUDE database was characteristically very, very small for oral appliances compared to many other treatments for OSA," says Richardson, clinical director at Houston Sleep Well. "And then I was like, ‘What in the world?’"
The data they uncovered, recently published in the Journal of Clinical Sleep Medicine, reveals that between 2013 and 2023, the average number of annual adverse event reports for these devices hovered around 41. In stark contrast, the years 2024 and 2025 saw a 10.1-fold increase compared to the previous four-year period. This investigation into the "why" behind these numbers has since ignited a broader conversation regarding regulatory compliance, the evolution of telehealth, and the inherent limitations of passive surveillance systems.
Chronology: A Fundamental Shift in Failure Types
The retrospective analysis conducted by Glick and Richardson categorized the data into two distinct periods to isolate the trend. "Period A" spanned from 2020 to 2023, while "Period B" covered the subsequent years of 2024 and 2025.
Period A (2020–2023): The Baseline
During this window, the annual report volume remained consistent with historical norms, with a mean of 42 reports per year. Notably, the clinical nature of these reports was predictable: approximately 78% of the filings were related to biocompatibility issues, such as allergic reactions to materials. Only 8.9% of reports involved mechanical failure, such as broken or fractured components.
Period B (2024–2025): The Deviation
In the most recent two-year period, the data shifted dramatically. The mean annual report volume surged to 423.5. In 2025 alone, the database logged 662 reports. Perhaps more significant than the volume was the shift in the type of reported event. In this cohort, broken or fractured devices accounted for 91.6% of all submissions, while allergy-related reports plummeted to just 4.8%.
"Historically, adverse events for oral appliances indicated for snoring and OSA have been infrequent and stable," says Glick, a dentist at Spira Dental Sleep Therapy. "The findings are so important because they’re a signal that something has potentially changed."
Supporting Data and the "Denominator" Problem
A critical challenge in interpreting the MAUDE data is the absence of a "denominator." The FDA’s MAUDE database is a passive surveillance system, meaning it tracks the reports it receives, but it does not know the total number of devices currently in use by patients. Without knowing the total volume of appliances sold or worn during the same period, experts cannot mathematically determine whether the failure rate has actually increased or if the reporting mechanism has simply become more efficient.
"Basically, we don’t know, right? There is no denominator," Richardson admits. "We don’t know how many devices were in use during that period, so we can’t determine incidence. What we can say is that it is unusual to see such a marked change over such a short period of time."
The FDA has long cautioned that MAUDE data should not be used to establish or compare event rates. It is a tool for identifying potential signals—"smoke"—but it cannot confirm the presence of a "fire" without supplementary, structured research.
Official Responses: Compliance vs. Safety
The study identified that a single product line, the "Silent Nite" manufactured by Prismatik Dentalcraft (a subsidiary of Glidewell Dental), accounted for 97.6% of the reports in the high-volume Period B. This finding immediately drew the attention of the manufacturer.
The Prismatik Perspective
Shelly Gallup, senior vice president of regulatory affairs and quality assurance at Prismatik Dentalcraft, argues that the surge is a result of improved administrative rigor rather than a degradation of product quality.
"The increase in MAUDE reports beginning in 2024 is primarily attributable to changes in how Prismatik captures and processes complaints, including centralized intake and expanded internal review," Gallup stated. She noted that as an FDA-registered medical device manufacturer, the company is bound by 21 C.F.R. Part 803, which mandates strict reporting. She suggested that because many smaller dental laboratories are not subject to the same level of federal oversight, the MAUDE database provides an skewed, incomplete picture of the industry. "Many other suppliers of oral appliances operate as dental laboratories and are not subject to the same reporting obligations," Gallup added.
The Telehealth/DTC Perspective
The rise of direct-to-consumer (DTC) models has also introduced new variables. The study noted that 42 reports involved DTC companies, with Daybreak accounting for 92.9% of that specific subset.
Peter Balacky, DDS, dental director at Daybreak, pushed back against the implication that their model is inherently riskier. He emphasized that the 42 reports attributed to the DTC subcategory represent only about 5% of the total dataset, and that Daybreak’s high reporting numbers are a byproduct of their digital-first, high-compliance business model.
"We report every qualifying event on a monthly cadence, an obligation individual dental practices generally don’t carry," Balacky explains. "That’s a function of compliance, not elevated risk." He further points out that Daybreak’s model involves consistent, scheduled follow-ups, which may simply catch mechanical issues that would go unrecorded in a traditional, less-digitized clinical setting.
Clinical Implications: The "Invisible" Side Effects
One of the most intriguing aspects of the study is the disconnect between clinical literature and MAUDE reports. Academic studies on oral appliances frequently discuss side effects such as bite changes, temporomandibular disorder (TMD), and periodontal shifts. Yet, these are rarely found in the FDA database.
Researchers hypothesize that these clinical side effects are managed locally by dentists in their private practices. When a patient experiences a minor shift in their bite, the dentist adjusts the appliance or monitors the patient, treating the issue as a routine clinical occurrence rather than a "device failure" that requires a federal report.
"Most dentists that are doing this are very good at handling side effects, and side effects are usually rare," Glick notes. "When they do happen, the treating dentists help keep the standards of quality that the public expects from the dental sleep field."
Future Directions: A Call for Transparency
The 2024–2025 reporting surge has effectively served as a canary in the coal mine, highlighting that the landscape of oral appliance therapy is changing. As manufacturers integrate more robust internal reporting systems and as telehealth models become more prominent, the volume of data submitted to federal regulators is expected to grow.
For the medical community, the takeaway is clear: the data is a starting point, not a conclusion. The shift from biocompatibility complaints to mechanical fracture reports suggests that the industry is becoming more aware of hardware durability, even if the actual failure rate remains constant.
Moving forward, stakeholders are calling for more rigorous, structured registries that include the missing "denominator" data. By moving beyond passive, voluntary reporting systems, the industry could gain a more accurate understanding of the long-term performance of these devices. Until then, dentists and sleep physicians are encouraged to continue prescribing these appliances, which remain a well-validated and effective treatment for the millions of Americans struggling with the health risks of untreated obstructive sleep apnea.
As Glick concludes, "The main point is there should be other studies. We highlighted that there needs to be further investigations. What we have done is present some of the information that we found in the MAUDE database as an early sign that there are some changes."
