PlainHospital

MEDTRONIC NAVIGATION, INC

Manufacturer adverse-event records for MEDTRONIC NAVIGATION, INC come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2012–2026 · heavy-book · typical Death-code · injury-light

Injury-mix signature

MEDTRONIC NAVIGATION, INC is lighter on Injury codes

Injury-coded event_type share is 4.4% (injury-light tercile) beside 0.29% Death-coded (typical). Volume band: heavy.

What the Injury-mix reading shows for MEDTRONIC NAVIGATION, INC

The standout signal for MEDTRONIC NAVIGATION, INC is Injury-mix: 4.4% Injury-coded (injury-light) beside 0.29% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair MEDTRONIC NAVIGATION, INC with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 19 device types, led in this extract by Malfunction at 23,899 (95.3% of event_type total). Peak single-year volume reaches 6,201 reports across 12 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

25,086
Total Reports
72
Event-type Death
1,115
Injury Reports
19
Device Types

Event Types

Malfunction 23,899 (95.3%)
Injury 1,115 (4.4%)
Death 72 (0.3%)

Patient Outcomes

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

23,827 (94.5%)
Required Intervention 723 (2.9%)
Other 335 (1.3%)
R 77 (0.3%)
Death 70 (0.3%)
Hospitalization 64 (0.3%)
H 35 (0.1%)
Disability 35 (0.1%)
O 22 (0.1%)
S 15 (0.1%)
Life Threatening 11 (0.0%)
D 4 (0.0%)
L 1 (0.0%)

Devices (19)

Device Reports
Neurological Stereotaxic Instrument 21,071
Orthopedic Stereotaxic Instrument 1,966
Ear, Nose, And Throat Stereotaxic Instrument 1,132
Powered Laser Surgical Instrument 605
Intervertebral Fusion Device With Bone Graft, Lumbar 106
Image-Intensified Fluoroscopic X-Ray System, Mobile 99
Interventional Fluoroscopic X-Ray System 36
Electrosurgical, Cutting & Coagulation & Accessories 31
Stylet, Surgical, General & Plastic Surgery 23
Orthopedic Manual Surgical Instrument 3
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 3
Hammer, Surgical 2
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri 2
System, Nuclear Magnetic Resonance Imaging 2
Cannula And Trocar, Suprapubic, Non-Disposable 1
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece 1
Screw, Fixation, Bone 1
Spinal Fixation System 1
System, X-Ray, Fluoroscopic, Image-Intensified 1

Yearly Trend

12
2012: 1
13
2013: 1
15
2015: 1
18
2018: 1,566
19
2019: 6,201
20
2020: 3,428
21
2021: 2,960
22
2022: 2,126
23
2023: 2,871
24
2024: 3,890
25
2025: 2,037
26
2026: 4

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