Stealth S8 Premium: medical device reports filed with FDA

187 reports name it, 2019–2020. Manufacturer given most often on reports: Medtronic Navigation. Product code HAW.

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.

187
device reports naming the brand: 0% of all MAUDE reports · about 26 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 98.9%
classified as malfunction: 92.2% across the product code; 0.5%
classified as death, as reported: 1 reports · not verified by FDA

187 medical device reports received by FDA name the brand "Stealth S8 Premium" (instrument stereotaxic); the manufacturer given most often on reports is Medtronic Navigation; received from March 2019 to July 2020. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 (98.9%), death (0.5%) and injury (0.5%); 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 (35.8%), mechanical problem (23%) and imprecision (16.6%). The patient problems coded most often are no patient involvement, tissue damage and death. 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

No report naming Stealth S8 Premium was received in the five years to August 2026; the latest was received in July 2020.

Event type and report source

Event type, as classified on the report

Death0.5%1

Injury0.5%1

Malfunction98.9%185

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%187

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

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	67	35.8%	7%
Mechanical problema mechanical problem	43	23%	10.9%
Imprecision	31	16.6%	13%
Display or visual feedback problem	18	9.6%	5.5%
Environmental compatibility problem	18	9.6%	3.1%
Computer software problema software problem	10	5.3%	4.5%
Output problem	8	4.3%	1.8%
Communication or transmission problemthe device could not communicate or transmit	6	3.2%	6.4%
Application program freezes or fails to launch	5	2.7%	7.4%
Material integrity problema problem with the device material	5	2.7%	5.3%
Device sensing problem	3	1.6%	6.1%
Electromagnetic compatibility problem	1	0.5%	0%
Mechanical jam	1	0.5%	0.5%

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	91	48.7%
Tissue damage	2	1.1%
Deaththe patient died; cause not stated by this term	1	0.5%
Hemorrhage/blood loss/bleeding	1	0.5%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Stealth S8 Premium	Product code HAW	All MAUDE reports
Reports	187	42,840	26,136,888
Share of that pool	—	0.4%	0%
Classified as death, per 1,000 reports	5	2	9
Classified as injury	0.5%	6.9%	36.2%
Classified as malfunction	98.9%	92.2%	62.3%
Filed by the manufacturer	100%	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%
Fusion Ent Navigation System	1,520	8	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%

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 Stealth S8 Premium reports

How many FDA reports name Stealth S8 Premium?

187 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (98.9%), death (0.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

human-device interface problem (35.8%), mechanical problem (23%), imprecision (16.6%), display or visual feedback problem (9.6%) and environmental compatibility problem (9.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Stealth S8 Premium 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.