2026 data FDA MAUDE openFDA

Orthopedic 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 MAUDE casebook

openFDA event book Orthopedic Stereotaxic Instrument MID-BOOK · MAUDE

#138 of 1000 · 19,167 reports · 2008–2026

  • BOOK 19,167 reports
  • RANK #138 of 1000
  • DEATH 11 death-typed
  • INJ 3,622 injury-typed
  • MALF 15,515 malfunction
  • SPAN 2008–2026
  • PEAK 2025: 3,344
  • PHOTO System

Nearest event-volume peer: System, Image Processing, Radiological (223 report gap)

Orthopedic Stereotaxic Instrument sits #138 of 1000 among tracked device types with 19,167 MAUDE reports spanning 2008–2026. 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 (-1.5 pp)
  • INJ 18.9% corpus 30.4% · below corpus mean (-11.5 pp)
  • MALF 80.9% corpus 64.5% · above corpus mean (+16.4 pp)

Lead product-problem code Break is 11% of coded problems · Lead manufacturer MAKO SURGICAL CORP. accounts for 31% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Orthopedic Stereotaxic Instrument in the event-volume neighbourhood

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

reports

What this shows Orthopedic Stereotaxic Instrument carries 19,167 MAUDE reports, ranked #138 of 1000.

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

Event Types

Malfunction 15,515 (80.9%)
Injury 3,622 (18.9%)
13 (0.1%)
Death 11 (0.1%)
Other 6 (0.0%)

Patient Outcomes

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

11,902 (59.8%)
Other 3,520 (17.7%)
Hospitalization 2,171 (10.9%)
Required Intervention 1,463 (7.4%)
R 474 (2.4%)
O 222 (1.1%)
H 69 (0.3%)
Disability 38 (0.2%)
S 18 (0.1%)
Death 9 (0.0%)
Life Threatening 8 (0.0%)
L 6 (0.0%)
Congenital Anomaly 3 (0.0%)
D 1 (0.0%)

Top Product Problems

Break 1,822
Mechanical Problem 1,776
Material Integrity Problem 1,267
Device Slipped 1,252
Detachment of Device or Device Component 1,165
Use of Device Problem 989
Incorrect, Inadequate or Imprecise Result or Readings 856
Insufficient Information 852
Imprecision 656
Human-Device Interface Problem 615
Fracture 613
Material Deformation 588
Application Program Problem: Parameter Calculation Error 562
Computer Software Problem 534
Adverse Event Without Identified Device or Use Problem 525
Unintended Application Program Shut Down 495
Connection Problem 467
Non Reproducible Results 436
Unintended Movement 351
Malposition of Device 317

Yearly Trend

08
2008: 1
09
2009: 4
10
2010: 4
11
2011: 10
12
2012: 60
13
2013: 36
14
2014: 245
15
2015: 466
16
2016: 750
17
2017: 1,076
18
2018: 1,230
19
2019: 1,585
20
2020: 2,746
21
2021: 1,696
22
2022: 1,568
23
2023: 1,493
24
2024: 2,354
25
2025: 3,344
26
2026: 499

Related Entities for Orthopedic Stereotaxic Instrument

Event Locations

10,476 (54.7%)
I 8,522 (44.5%)
HOSPITAL 112 (0.6%)
NO INFORMATION 30 (0.2%)
OTHER 26 (0.1%)
NOT APPLICABLE 1 (0.0%)

Compare MAKO SURGICAL CORP. vs BLUE BELT TECHNOLOGIES →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Orthopedic Stereotaxic Instrument, 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 (19,167 here).

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

Disclaimer: MAUDE figures for Orthopedic 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 Orthopedic 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.