Top 10 Medical Devices by FDA MAUDE Adverse-Event Reports
PlainHospital ranks medical devices in the FDA MAUDE adverse-event database by total report count, using the maude_devices aggregate. Updated automatically as new data is processed.
Research period:
Research question
Among the medical devices tracked in the FDA MAUDE adverse-event database, which devices accumulate the highest total report counts, and what does report-volume concentration tell us about device-class market saturation versus device-specific safety profiles?
Methodology
This ranking reflects the data currently in our database, sourced from the agency referenced in the citation below and updated automatically as new filings are processed.
Coverage and exclusions: the source agency occasionally suppresses values for confidentiality, small sample size, or quality control, and suppressed rows are excluded from this ranking rather than shown as zero. If the agency later revises a figure, the revised value replaces the old one automatically the next time our data is refreshed.
Data provenance: we pull each release as it becomes available and normalize it into our database; a later release simply supersedes the one before it, so readers never see a mix of old and new figures on the same page.
Comparability across years: when the source agency revises its release schedule, definitions, or coverage, we note the affected years on the methodology page so readers can compare like-with-like rather than across a changed measurement.
Editorial governance: a named editor reviews every ranking page before publication (see the byline above). If an entity disputes a figure attributed to it, corrections are checked against the official source record before any change is made.
Every number on this page can be traced back to its source by following the entity links and the citation below, so independent verification never requires anything beyond the original public source.
See the methodology page for the complete ETL pipeline, source vintage, and column lineage.
Top 10 Medical Devices by FDA MAUDE Adverse-Event Reports
Live data: reflects the current dataset
The ranked top 10
Every row below reflects the current 10-record dataset. Reload the page after new data is processed to see the latest values.
| # | Device | Total MAUDE reports | Death-coded reports | Injury-coded reports |
|---|---|---|---|---|
| 1 | Implant, Endosseous, Root-Form | 3,537,615 | 42 | 3,507,501 |
| 2 | Integrated Continuous Glucose Monitoring System, Factory Calibrated | 1,913,309 | 174 | 31,666 |
| 3 | Pump, Infusion | 1,803,616 | 1,709 | 23,875 |
| 4 | Alternate Controller Enabled Insulin Infusion Pump | 1,088,188 | 213 | 114,774 |
| 5 | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 886,701 | 2,248 | 126,522 |
| 6 | Automated Insulin Dosing Device System, Single Hormonal Control | 838,920 | 1,227 | 122,353 |
| 7 | Pump, Infusion, Insulin | 534,449 | 1,407 | 95,739 |
| 8 | Automated Insulin Dosing , Threshold Suspend | 438,789 | 1,530 | 90,580 |
| 9 | System, Test, Blood Glucose, Over The Counter | 429,427 | 113 | 37,830 |
| 10 | Implantable Cardioverter Defibrillator (Non-Crt) | 369,312 | 10,004 | 220,498 |
Source: U.S. Food and Drug Administration, FDA MAUDE, Manufacturer and User Facility Device Experience Database. Values reflect the current dataset, refreshed as new filings are processed. U.S. Food and Drug Administration, FDA MAUDE, Manufacturer and User Facility Device Experience Database. Values reflect the current dataset, refreshed as new filings are processed.
Findings
Top entity in the ranking
The top-ranked record in this dataset is Implant, Endosseous, Root-Form, with a value of 3,537,615 on the Total MAUDE reports column. The full top-10 set is rendered in the table above. Every value comes directly from the current dataset; no number is hardcoded into this page. When the U.S. Food and Drug Administration publishes a revision, the ranking and the prose around it update automatically.
Distribution shape
The gap between the top-ranked record (3,537,615) and the 10th-ranked record (369,312) characterizes how concentrated the top of the distribution is. Where the top value is many multiples of the median value of the visible set, the population is highly concentrated, a small number of entities accumulate the bulk of the measured quantity. Where the top and bottom of the visible set are close together, the distribution is relatively flat across the top end. The full distribution beyond this top-10 cut is summarized in the aggregate context section below and explored in the linked entity profiles.
Aggregate context
Across the full population behind this ranking, here are the summary statistics: how many records exist in total, the sum of the ranking metric across all qualifying records, and the mean per-record value. The methodology page documents the exact filter applied (records with null or zero values on the ranking metric are excluded). This aggregate row is computed from the same dataset that powers the ranking above.
Source provenance
The records in this ranking originate from U.S. Food and Drug Administration, specifically the FDA MAUDE, Manufacturer and User Facility Device Experience Database. PlainHospital ingests the source vintage published by the agency and keeps this page current, there is no static export carrying stale numbers, and a newly published dataset is reflected here within hours. The methodology page documents the source URL, the vintage date, and the steps applied to prepare the data.
Why this ranking matters
Rankings like this one let a reader scan a population quickly and identify outliers, concentrations, and patterns that warrant deeper investigation. The detail pages linked from each entity in the table above give the full per-entity context: time-series history where available, related metrics from adjacent tables, and links onward to the underlying source records. The methodology page explains how an entity earns inclusion in the dataset and how the ranking column is computed at the source.
What this analysis cannot tell us
FDA MAUDE (Manufacturer and User Facility Device Experience) is a voluntary adverse-event reporting system; report volume reflects reporting behavior as much as actual device safety. A device with very high market penetration (insulin pumps, glucose monitors, endosseous dental implants) naturally accumulates more reports than a niche device, even at equivalent per-unit risk. Death and injury counts are coded by the reporter (manufacturer, user facility, healthcare professional, patient) and may not reflect adjudicated causality, a report may be coded as a death event even when the device contribution is uncertain. MAUDE excludes some product categories tracked under separate FDA reporting systems (vaccines, blood products, combination products). Reports are not deduplicated across submitting entities, a single adverse event reported by both the user facility and the manufacturer counts as two reports. FDA recommends MAUDE be used to generate hypotheses about device safety signals rather than as a denominator for adverse-event rates, because the underlying population at risk (device-days of use) is not captured.
Secondary cut from the same source
Top 10 medical devices by death-coded MAUDE reports, death-coding indicates a reporter classified the event as contributing to or causing patient death
Sources
- FDA, MAUDE Database - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm
- openFDA, Device Endpoint - https://open.fda.gov/apis/device/
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. This page draws directly on federal source data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.