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2026 data FDA MAUDE openFDA FDA Class II

Neurological 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 Neurological Stereotaxic Instrument MID-BOOK · MAUDE

#81 of 1000 · 42,726 reports · 1994–2026

  • BOOK 42,726 reports
  • RANK #81 of 1000
  • DEATH 104 death-typed
  • INJ 2,948 injury-typed
  • MALF 39,412 malfunction
  • SPAN 1994–2026
  • PEAK 2019: 6,062
  • PHOTO Clip, Implantable

Nearest event-volume peer: Clip, Implantable (522 report gap)

Neurological Stereotaxic Instrument sits #81 of 1000 among tracked device types with 42,726 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

Neurological Stereotaxic Instrument carries 92.2% MALFUNCTION-coded reports, 27.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 6.9% corpus 30.3% · below corpus mean (-23.4 pp)
  • MALF 92.2% corpus 64.8% · above corpus mean (+27.4 pp)

Lead product-problem code Imprecision is 12% of coded problems · Lead manufacturer MEDTRONIC NAVIGATION, INC accounts for 55% of manufacturer-tagged reports · Top event location I is 53% of location-tagged rows .

Neurological Stereotaxic Instrument in the event-volume neighbourhood

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

reports

What this shows Neurological Stereotaxic Instrument carries 42,726 MAUDE reports, ranked #81 of 1000.

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

Event Types

Malfunction 39,412 (92.2%)
Injury 2,948 (6.9%)
Other 134 (0.3%)
128 (0.3%)
Death 104 (0.2%)

Patient Outcomes

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

39,171 (91.2%)
Required Intervention 1,596 (3.7%)
Other 1,345 (3.1%)
R 206 (0.5%)
Hospitalization 185 (0.4%)
Death 107 (0.2%)
O 87 (0.2%)
Disability 74 (0.2%)
S 63 (0.1%)
H 46 (0.1%)
Life Threatening 46 (0.1%)
L 11 (0.0%)
Congenital Anomaly 6 (0.0%)
D 4 (0.0%)

Top Product Problems

Imprecision 5,561
Mechanical Problem 4,630
Application Program Freezes or Fails to Launch 3,170
Human-Device Interface Problem 3,019
Device Operates Differently Than Expected 2,774
Communication or Transmission Problem 2,736
Application Program Problem 2,694
Device Sensing Problem 2,595
Display or Visual Feedback Problem 2,335
Material Integrity Problem 2,254
Computer Software Problem 1,909
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1,900
Incorrect, Inadequate or Imprecise Result or Readings 1,725
Adverse Event Without Identified Device or Use Problem 1,506
Environmental Compatibility Problem 1,319
Break 1,222
Device Stops Intermittently 1,053
Use of Device Problem 1,009
Material Deformation 948
Output Problem 763

Yearly Trend

94
1994: 1
96
1996: 3
97
1997: 12
98
1998: 5
99
1999: 4
00
2000: 6
01
2001: 6
02
2002: 7
03
2003: 7
04
2004: 12
05
2005: 22
06
2006: 32
07
2007: 49
08
2008: 53
09
2009: 96
10
2010: 299
11
2011: 1,725
12
2012: 986
13
2013: 1,290
14
2014: 1,606
15
2015: 1,767
16
2016: 1,829
17
2017: 3,502
18
2018: 4,439
19
2019: 6,062
20
2020: 3,480
21
2021: 2,827
22
2022: 1,929
23
2023: 2,510
24
2024: 3,755
25
2025: 3,484
26
2026: 921

Reports in 2025 (3,484) held close to the prior two-year average of 3,133.

Related Entities for Neurological Stereotaxic Instrument

Top Manufacturers

MEDTRONIC NAVIGATION, INC 21,078
MEDTRONIC NAVIGATION, INC. 7,994
MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 7,032
STRYKER INSTRUMENTS-KALAMAZOO 1,670
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 226

Event Locations

I 22,699 (53.1%)
19,788 (46.3%)
HOSPITAL 138 (0.3%)
OTHER 50 (0.1%)
NO INFORMATION 30 (0.1%)
NOT APPLICABLE 9 (0.0%)
AMBULATORY SURGICAL FACILITY 4 (0.0%)
UNKNOWN 4 (0.0%)
INVALID DATA 3 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Neurological 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 (42,726 here).

Clip, Implantable 42,204 Catheters 43,512 Dialyzer 43,552 Stimulator, Spinal-Cord, Implanted 43,932

Similar death-typed counts

Nearest other device types by death-typed report count (104 here), distinct from the volume row.

Catheter, Septostomy 104 Interventional Fluoroscopic X-Ray System 105 Stent, Colonic, Metallic, Expandable 105 Separator 106

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

Disclaimer: MAUDE figures for Neurological 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 Neurological 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.