A recent, dramatic surge in adverse event reports for mandibular advancement devices (MADs)—the oral appliances commonly used to treat obstructive sleep apnea (OSA)—has sent ripples through the dental sleep medicine community. For over a decade, the safety profile for these devices had remained remarkably stable and predictable. However, data from the Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database indicates a 10.1-fold increase in reported events between 2024 and 2025.
This unexpected spike has prompted a critical investigation into whether the industry is witnessing a genuine decline in device quality, a systemic change in corporate reporting culture, or simply a byproduct of how newer digital health models interact with federal surveillance systems.
The Catalyst: An Unexpected Discovery
The investigation into these numbers was serendipitous. While preparing for a professional webinar on the regulatory landscape of oral appliances, dentists Sue Ellen Richardson, DDS, DABDSM, FAASM, and Aaron Glick, DDS, FICOI, FAGD, DABDSM, performed a standard check of 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 obstructive sleep apnea," explains Richardson, clinical director at Houston Sleep Well. "And then I was like, ‘What in the world?’"
Their confusion was well-founded. Between 2013 and 2023, the annual average for adverse event reports regarding these devices hovered consistently around 41. In 2025 alone, that number exploded to 662. This statistical anomaly, documented in their recent study published in the Journal of Clinical Sleep Medicine, marks a definitive departure from historical trends.
A Chronology of Reporting Trends
To better understand the phenomenon, researchers Glick and Richardson categorized the data into two distinct cohorts:
- Period A (2020–2023): This period maintained the historical norm, with a mean annual report volume of 42.0.
- Period B (2024–2025): This period saw a massive escalation, with a mean of 423.5 reports per year.
The transition between these two periods also marked a qualitative shift. In the earlier cohort, approximately 78% of all reports were related to biocompatibility issues or patient allergies. Conversely, in the 2024–2025 period, 91.6% of reports cited mechanical failures, such as broken or fractured devices, 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 Dr. Glick. "The findings are so important because they’re a signal that something has potentially changed."
Deconstructing the Data: Why the Spike?
The primary driver behind the surge appears to be a concentration of reports from a single manufacturer: Prismatik Dentalcraft, a subsidiary of Glidewell Dental. Their "Silent Nite" product line accounted for 97.6% of the reports identified in the 2024–2025 cohort.
The Manufacturer’s Position
Prismatik Dentalcraft points to internal administrative restructuring as the catalyst for the reporting influx. Shelly Gallup, senior vice president of regulatory affairs and quality assurance at Prismatik, clarifies that the spike is not necessarily indicative of a failing product, but rather a more rigorous approach to compliance.
"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 noted. She emphasizes that as an FDA-registered manufacturer, Prismatik is strictly bound by 21 C.F.R. Part 803—a mandate that many smaller dental laboratories, which often act as appliance suppliers, may not strictly adhere to.
According to Prismatik, the Silent Nite device has maintained a consistent safety record since its 510(k) clearance in 1997. The current surge, they argue, is a reflection of their commitment to transparency and federal regulatory adherence rather than a decline in manufacturing standards.
The Telehealth Factor
The emergence of direct-to-consumer (DTC) and telehealth models has added another layer of complexity. Critics of these models often argue that remote care lacks the "human touch" necessary for identifying clinical issues early. However, representatives from companies like Daybreak, a telehealth-enabled provider, argue that their digital platforms inherently encourage more frequent reporting.
Peter Balacky, DDS, dental director at Daybreak, notes that while their company appeared in the dataset, it represented only a small fraction of the total. "We report every qualifying event on a monthly cadence, an obligation individual dental practices generally don’t carry," Balacky explains. "Our data will naturally appear more complete in a passive system like MAUDE. That’s a function of compliance, not elevated risk."
The "Denominator" Problem
A recurring theme in the discourse surrounding the MAUDE database is the lack of "denominator" data. In epidemiological terms, the database records the number of events, but it does not provide the total number of devices in use. Without knowing the exact number of appliances sold or currently worn by patients, researchers cannot calculate a true incidence rate or risk percentage.
"Basically, we don’t know, right? There is no denominator," says Dr. Richardson. "We don’t know how many devices were in use during that period, so we can’t determine incidence."
The FDA itself warns that the MAUDE database is a passive surveillance tool, not a clinical registry. It is intended to help identify potential safety signals, but it is not a scientific instrument designed for comparative statistical analysis.
Clinical Implications: Separating Fact from Fear
Despite the alarming raw numbers, the consensus among dental sleep medicine professionals is that oral appliances remain a safe and highly effective treatment for OSA. The fractures cited in the reports were, in the vast majority of cases, non-injurious.
Furthermore, there is a distinct disconnect between the failures reported to the FDA and the issues dentists treat in their offices. Clinical literature often focuses on side effects like temporomandibular disorder (TMD), bite changes, and periodontal issues. These are rarely reported to the FDA, likely because they are managed effectively by the prescribing dentist during follow-up appointments.
"Most dentists that are doing this are very good at handling side effects, and side effects are usually rare," says Dr. Glick. "When they do happen, the treating dentists help keep the standards of quality that the public expects from the dental sleep field."
Looking Ahead: The Future of Device Surveillance
The 2024–2025 surge in MAUDE reporting should be viewed as a signal for further investigation, not a signal to abandon established therapies. As the landscape of OSA treatment evolves—incorporating more digital workflows, telehealth oversight, and centralized manufacturing compliance—the nature of how we monitor these devices must evolve as well.
The study by Glick and Richardson serves as a call to action for the industry to move toward more robust, active surveillance. By developing registries that track total device usage and clinical outcomes, the dental sleep community can move beyond the limitations of passive, anecdotal reporting.
For now, patients and clinicians should feel reassured that the "fundamental shift" seen in the FDA database is largely an administrative and procedural evolution. As the industry matures, the focus remains clear: providing accessible, safe, and effective care to the millions of Americans struggling with obstructive sleep apnea. Transparency, even when it manifests as a sudden spike in paperwork, is ultimately a pillar of high-quality, patient-centered care.
Reference:
Glick A, Richardson SE. "Increasing reports and shifting categorical trends in adverse events for oral appliances." Journal of Clinical Sleep Medicine. 2026 Jul 22;22(1):121.
