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2026 data FDA MAUDE openFDA FDA Class II

Ear, Nose, And Throat Stereotaxic Instrument

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 II (moderate risk, special controls required), regulated under 21 CFR §882.4560 (Neurology panel).

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FDA MAUDE casebook

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

#534 of 1000 · 1,712 reports · 2014–2026

  • BOOK 1,712 reports
  • RANK #534 of 1000
  • DEATH 1 death-typed
  • INJ 57 injury-typed
  • MALF 1,654 malfunction
  • SPAN 2014–2026
  • PEAK 2024: 274
  • PHOTO Transmitters And Rece…

Nearest event-volume peer: Transmitters And Receivers, Physiological Signal, Radiofrequency (2 report gap)

Ear, Nose, And Throat Stereotaxic Instrument sits #534 of 1000 among tracked device types with 1,712 MAUDE reports spanning 2014–2026. 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

Ear, Nose, And Throat Stereotaxic Instrument carries 96.6% MALFUNCTION-coded reports, 31.8pp 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 3.3% corpus 30.3% · below corpus mean (-27.0 pp)
  • MALF 96.6% corpus 64.8% · above corpus mean (+31.8 pp)

Lead product-problem code Application Program Freezes or Fails to Launch is 13% of coded problems · Lead manufacturer MEDTRONIC NAVIGATION, INC accounts for 77% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Ear, Nose, And Throat Stereotaxic Instrument in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Ear, Nose, And Throat Stereotaxic Instrument carries 1,712 MAUDE reports, ranked #534 of 1000.

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

Event Types

Malfunction 1,654 (96.6%)
Injury 57 (3.3%)
Death 1 (0.1%)

Patient Outcomes

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

1,627 (95.5%)
Required Intervention 31 (1.8%)
Life Threatening 13 (0.8%)
R 8 (0.5%)
Other 8 (0.5%)
L 7 (0.4%)
Hospitalization 7 (0.4%)
H 1 (0.1%)
Death 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Application Program Freezes or Fails to Launch 267
Human-Device Interface Problem 207
Imprecision 184
Display or Visual Feedback Problem 178
Device Sensing Problem 177
Communication or Transmission Problem 129
Incorrect Interpretation of Signal 129
Mechanical Problem 118
Application Program Problem 117
Incorrect, Inadequate or Imprecise Result or Readings 117
Material Integrity Problem 71
Incorrect Measurement 60
Environmental Compatibility Problem 59
Adverse Event Without Identified Device or Use Problem 58
Connection Problem 55
Device Operates Differently Than Expected 44
Use of Device Problem 43
Computer Software Problem 42
Output Problem 36
Device Stops Intermittently 23

Yearly Trend

14
2014: 7
15
2015: 14
16
2016: 33
17
2017: 42
18
2018: 96
19
2019: 247
20
2020: 161
21
2021: 190
22
2022: 166
23
2023: 200
24
2024: 274
25
2025: 220
26
2026: 62

Reports in 2025 (220) held close to the prior two-year average of 237.

Related Entities for Ear, Nose, And Throat Stereotaxic Instrument

Top Manufacturers

MEDTRONIC NAVIGATION, INC 1,132
MEDTRONIC NAVIGATION, INC. 148
MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 101
STRYKER INSTRUMENTS-KALAMAZOO 43
BIOSENSE WEBSTER INC 21
MEDTRONIC INC 8
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 6
MEDTRONIC INC. 4

Event Locations

975 (57.0%)
I 730 (42.6%)
HOSPITAL 6 (0.4%)
NO INFORMATION 1 (0.1%)

Compare MEDTRONIC NAVIGATION, INC vs MEDTRONIC NAVIGATION, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Ear, Nose, And Throat Stereotaxic Instrument: 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 (1,712 here).

Transmitters And Receivers 1,714 Sleeve, Limb, Compressible 1,705 Covid-19 Multi-Analyte Respiratory Panel Nu… 1,693 Prosthesis 1,692

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Ear, Nose, And Throat Stereotaxic Instrument 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 Ear, Nose, And Throat Stereotaxic Instrument; 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.