2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Bur, Ear, Nose And Throat LIGHT-BOOK · MAUDE

#427 of 1000 · 2,629 reports · 1994–2026

  • BOOK 2,629 reports
  • RANK #427 of 1000
  • DEATH 3 death-typed
  • INJ 157 injury-typed
  • MALF 2,450 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 445
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal (8 report gap)

Bur, Ear, Nose And Throat sits #427 of 1000 among tracked device types with 2,629 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 6.0% corpus 30.4% · below corpus mean (-24.5 pp)
  • MALF 93.2% corpus 64.5% · above corpus mean (+28.7 pp)

Lead product-problem code Break is 46% of coded problems · Lead manufacturer MEDTRONIC XOMED INC. accounts for 84% of manufacturer-tagged reports · Top event location is 61% 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

reports

What this shows Bur, Ear, Nose And Throat carries 2,629 MAUDE reports, ranked #427 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 2,450 (93.2%)
Injury 157 (6.0%)
Other 16 (0.6%)
3 (0.1%)
Death 3 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

2,426 (91.9%)
Required Intervention 125 (4.7%)
Other 63 (2.4%)
R 13 (0.5%)
Hospitalization 9 (0.3%)
S 2 (0.1%)
L 1 (0.0%)
Death 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Break 1,135
Vibration 545
Material Fragmentation 215
Material Separation 161
Physical Resistance/Sticking 115
Mechanical Jam 88
Overheating of Device 42
Connection Problem 30
Noise, Audible 22
Use of Device Problem 22
Mechanical Problem 17
Adverse Event Without Identified Device or Use Problem 11
Failure to Cut 11
Material Twisted/Bent 10
Device Markings/Labelling Problem 9
Contamination /Decontamination Problem 6
Fracture 6
Inability to Irrigate 6
Unintended Movement 6
Fitting Problem 5

Yearly Trend

94
1994: 4
97
1997: 1
98
1998: 1
00
2000: 2
03
2003: 1
04
2004: 4
06
2006: 7
07
2007: 21
08
2008: 21
09
2009: 10
10
2010: 30
11
2011: 65
12
2012: 84
13
2013: 76
14
2014: 95
15
2015: 93
16
2016: 95
17
2017: 118
18
2018: 204
19
2019: 129
20
2020: 100
21
2021: 131
22
2022: 229
23
2023: 261
24
2024: 368
25
2025: 445
26
2026: 34

Related Entities for Bur, Ear, Nose And Throat

Event Locations

1,606 (61.1%)
I 930 (35.4%)
HOSPITAL 68 (2.6%)
NO INFORMATION 11 (0.4%)
AMBULATORY SURGICAL FACILITY 7 (0.3%)
OTHER 4 (0.2%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)
UNKNOWN 1 (0.0%)

Compare MEDTRONIC XOMED INC. vs MEDTRONIC XOMED, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Bur, Ear, Nose And Throat, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,629 here).

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

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.