Bur, Ear, Nose And Throat
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §874.4140 (Ear, Nose, Throat panel).
FDA MAUDE casebook
openFDA event book Bur, Ear, Nose And Throat LIGHT-BOOK · MAUDE
#433 of 1000 · 2,714 reports · 1994–2026
- BOOK 2,714 reports
- RANK #433 of 1000
- DEATH 3 death-typed
- INJ 158 injury-typed
- MALF 2,534 malfunction
- SPAN 1994–2026
- PEAK 2025: 445
- PHOTO Vehicle
Nearest event-volume peer: Vehicle, Motorized 3-Wheeled (1 report gap)
Bur, Ear, Nose And Throat sits #433 of 1000 among tracked device types with 2,714 MAUDE reports spanning 1994–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Bur, Ear, Nose And Throat carries 93.4% MALFUNCTION-coded reports, 28.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 5.8% corpus 30.3% · below corpus mean (-24.5 pp)
- MALF 93.4% corpus 64.8% · above corpus mean (+28.5 pp)
Lead product-problem code Break is 48% of coded problems · Lead manufacturer MEDTRONIC XOMED INC. accounts for 84% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .
Bur, Ear, Nose And Throat in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- System
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
2,731 reports
- Drills
Drills, Burrs, Trephines & Accessories (Compound, Powered)
2,726 reports
- Vehicle
Vehicle, Motorized 3-Wheeled
2,715 reports
- Bur (this)
Bur, Ear, Nose And Throat
2,714 reports
- Forceps
Forceps, Biopsy, Non-Electric
2,705 reports
- Prosthesis
Prosthesis, Hip, Hemi-, Femoral, Metal
2,683 reports
What this shows Bur, Ear, Nose And Throat carries 2,714 MAUDE reports, ranked #433 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 445 in 2025, up from an average of 315 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Bur, Ear, Nose And Throat
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Bur, Ear, Nose And Throat: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (2,714 here).
Similar death-typed counts
Nearest other device types by death-typed report count (3 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Bur, Ear, Nose And Throat are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Bur, Ear, Nose And Throat; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.