Device manufacturer, as written on reports

Medtronic Navigation: medical device reports filed with FDA

34,350 reports name it as the manufacturer of the device involved, 2006–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

34,350
reports naming it as manufacturer: 0.1% of all MAUDE reports; 2,156
reports, 12 months to August 2026: 4,728 in the 12 months before; 94.7%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

34,350 medical device reports received by FDA give Medtronic Navigation as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2006 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

2,156 reports arrived in the 12 months to August 2026, down 54% from 4,728 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (94.7%), injury (4.8%) and death (0.3%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
StealthStation S8 system	Neurological stereotaxic instrument	10,818	1,368	0.1%
Stealthstation S7 System	Neurological stereotaxic instrument	2,499	0	0.4%
Stealthstation S7	Neurological stereotaxic instrument	2,197	30	0.4%
Fusion Ent Navigation System	Neurological stereotaxic instrument	1,506	8	0%
Stealthstation Treon Treatment Guidance System	Neurological stereotaxic instrument	886	0	0.4%
Fusion Navigation System	Neurological stereotaxic instrument	883	0	0%
Medtronic Navigation	Neurological stereotaxic instrument	652	69	6.7%
Cart 9734056 S7 Staff Shrt 100-120v Intl	Neurological stereotaxic instrument	581	4	0%
StealthStation FlexENT	Ear, nose, and throat stereotaxic instrument	565	55	0%
Stealthstation S8 Premium System	Neurological stereotaxic instrument	507	0	0%
Visualase	Powered laser surgical instrument	472	48	0.8%
NavLock	Orthopedic stereotaxic instrument	419	90	0%
S7	Neurological stereotaxic instrument	355	0	0%
Stealthstation S7 Navigation	Neurological stereotaxic instrument	355	1	0%
Fusion Compact	Ear, nose, and throat stereotaxic instrument	332	7	0%
Cart 9733856 S7 Staff Assembled 110v	Neurological stereotaxic instrument	294	0	0%
Surgn Cart 9735665 Stealth S8 Premium	Neurological stereotaxic instrument	290	0	0%
Stealthstation	Neurological stereotaxic instrument	280	0	0%
S8 Premium	Neurological stereotaxic instrument	264	0	0%
S7 Stealthstation Navigation System	Neurological stereotaxic instrument	253	0	0.4%
Open Spine Clamp Titanium	Neurological stereotaxic instrument	248	0	0%
Stealthstation I7 Integrated Navigation System	Neurological stereotaxic instrument	215	0	0%
Stealth S8 Premium	Neurological stereotaxic instrument	187	0	0.5%
Stealthstation S8 Em Ent System	Neurological stereotaxic instrument	164	0	0%
Perc Pin	Orthopedic stereotaxic instrument	161	0	0%
Patient Tracker 9734887xom Non-Invasive	Neurological stereotaxic instrument	155	7	0%
Stealthstation Tria Navigation System	Neurological stereotaxic instrument	114	0	0.6%
Biopsy Guide	Neurological stereotaxic instrument	70	7	0.6%
O-Arm 1000 Imaging System	Image-intensified fluoroscopic x-ray system, mobile	58	2	0%
O-Arm O2 Imaging System	Interventional fluoroscopic x-ray system	22	681	0.1%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
HAW	Neurological stereotaxic instrument	29,421	85.7%
OLO	Orthopedic stereotaxic instrument	2,546	7.4%
PGW	Ear, nose, and throat stereotaxic instrument	1,305	3.8%
GEX	Powered laser surgical instrument	680	2%
MAX	Intervertebral fusion device with bone graft, lumbar	131	0.4%
OXO	Image-intensified fluoroscopic x-ray system, mobile	109	0.3%
GEI	Electrosurgical, cutting & coagulation & accessories	90	0.3%
OWB	Interventional fluoroscopic x-ray system	45	0.1%
IZL	System, x-ray, mobile	29	0.1%
LNH	System, nuclear magnetic resonance imaging	10	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.3%90

Injury4.8%1,657

Malfunction94.7%32,542

Other0.1%36

Not given0.1%25

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Medtronic Navigation reports

How many FDA device reports name Medtronic Navigation as manufacturer?

34,350 reports through August 2026, 2,156 of them in the latest 12 months.

Which of its brands appear most often?

StealthStation S8 system (10,818), Stealthstation S7 System (2,499), Stealthstation S7 (2,197), Fusion Ent Navigation System (1,506) and Stealthstation Treon Treatment Guidance System (886).

Which device types does it report on?

neurological stereotaxic instrument (85.7%), orthopedic stereotaxic instrument (7.4%), ear, nose, and throat stereotaxic instrument (3.8%) and powered laser surgical instrument (2%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.