Devices › Neurological stereotaxic instrument
Device brand name · Instrument stereotaxic
Fusion Ent Navigation System: medical device reports filed with FDA
1,520 reports name it, 2018–2026. Manufacturer given most often on reports: Medtronic Navigation. Product code HAW.
- 1,520
- device reports naming the brand
- 0% of all MAUDE reports · about 194 a year
- 8
- reports, 12 months to August 2026
- 85 in the 12 months before
- 98.8%
- classified as malfunction
- 92.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,520 medical device reports received by FDA name the brand "Fusion Ent Navigation System" (instrument stereotaxic); the manufacturer given most often on reports is Medtronic Navigation; received from September 2018 to May 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
8 reports arrived in the 12 months to August 2026, down 91% from 85 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 (98.8%) and injury (1.3%); across all neurological stereotaxic instrument reports (product code HAW) death is recorded in 0.2% and malfunction in 92.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are human-device interface problem (24.5%), application program freezes or fails to launch (17.9%) and mechanical problem (15.7%). The patient problems coded most often are no patient involvement, cerebrospinal fluid leakage and complaint, ill-defined. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 42,840 reports carrying product code HAW. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Human-device interface problem | 372 | 24.5% | 7% |
| Application program freezes or fails to launch | 272 | 17.9% | 7.4% |
| Mechanical problema mechanical problem | 239 | 15.7% | 10.9% |
| Display or visual feedback problem | 179 | 11.8% | 5.5% |
| Communication or transmission problemthe device could not communicate or transmit | 144 | 9.5% | 6.4% |
| Imprecision | 121 | 8% | 13% |
| Device sensing problem | 116 | 7.6% | 6.1% |
| Environmental compatibility problem | 107 | 7% | 3.1% |
| Output problem | 80 | 5.3% | 1.8% |
| Material integrity problema problem with the device material | 77 | 5.1% | 5.3% |
| Application program problem | 46 | 3% | 6.3% |
| Computer software problema software problem | 37 | 2.4% | 4.5% |
| Connection problema connection problem | 37 | 2.4% | 1.8% |
| Computer operating system problem | 12 | 0.8% | 0.4% |
| Incorrect, inadequate or imprecise result or readings | 7 | 0.5% | 4.1% |
| Excessive heating | 6 | 0.4% | 0.2% |
| Electrical /electronic property probleman electrical or electronic problem | 5 | 0.3% | 1.4% |
| Power problem | 5 | 0.3% | 0.3% |
| Unexpected shutdown | 5 | 0.3% | 0.8% |
| Delayed program or algorithm execution | 4 | 0.3% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 525 | 34.5% |
| Cerebrospinal fluid leakage | 3 | 0.2% |
| Complaint, ill-defined | 3 | 0.2% |
| Tissue damage | 2 | 0.1% |
| Headachehead pain | 1 | 0.1% |
| Hemorrhage/blood loss/bleeding | 1 | 0.1% |
| Iatrogenic source | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Fusion Ent Navigation System | Product code HAW | All MAUDE reports |
|---|---|---|---|
| Reports | 1,520 | 42,840 | 26,136,888 |
| Share of that pool | — | 3.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 1.3% | 6.9% | 36.2% |
| Classified as malfunction | 98.8% | 92.2% | 62.3% |
| Filed by the manufacturer | 99.9% | 99.5% | 94.9% |
Shares are of reports, not 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."
Other brands with product code HAW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| StealthStation S8 system | 10,870 | 1,368 | 0.1% |
| Stealthstation S7 System | 5,989 | 0 | 0.4% |
| Stealthstation S7 | 2,207 | 30 | 0.4% |
| Fusion Navigation System | 2,165 | 0 | 0% |
| Stealthstation S8 Premium System | 1,007 | 0 | 0% |
| Stealthstation Treon Treatment Guidance System | 961 | 0 | 0.4% |
| Cart 9734056 S7 Staff Shrt 100-120v Intl | 904 | 4 | 0% |
| Rosa Surgical Device | 711 | 0 | 0% |
| Rosa Brain | 675 | 0 | 0.1% |
| Rosa One | 595 | 0 | 0% |
| Medtronic Navigation | 682 | 69 | 6.7% |
| Stealthstation I7 Integrated Navigation System | 471 | 0 | 0% |
| Open Spine Clamp Titanium | 445 | 0 | 0% |
| Stealthstation S7 Navigation | 366 | 1 | 0% |
| S7 | 363 | 0 | 0% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Fusion Ent Navigation System reports
How many FDA reports name Fusion Ent Navigation System?
1,520 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 8 in the latest 12 months.
What kinds of events are reported?
malfunction (98.8%) and injury (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
human-device interface problem (24.5%), application program freezes or fails to launch (17.9%), mechanical problem (15.7%), display or visual feedback problem (11.8%) and communication or transmission problem (9.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Fusion Ent Navigation System was at fault?
No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.