Neurological stereotaxic instrument: medical device reports filed with FDA

42,840 reports carry this product code, 1994–2026; 30 brands with a page.

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.

42,840
reports with this product code: 0.2% of all MAUDE reports; 1,803
reports, 12 months to August 2026: 4,201 in the 12 months before; 92.2%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code HAW is FDA's classification for "Neurological stereotaxic instrument" (neurology panel), a class 2 device. 42,840 medical device reports carry this product code, 0.2% of the MAUDE database, from February 1994 to August 2026.

1,803 reports arrived in the 12 months to August 2026, down 57% from 4,201 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 (92.2%), injury (6.9%) and other (0.3%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
StealthStation S8 system	10,817	1,368	0.1%	97.7%
Stealthstation S7 System	5,977	0	0.4%	90.3%
Stealthstation S7	2,205	30	0.4%	95.7%
Fusion Navigation System	2,160	0	0%	97.5%
Fusion Ent Navigation System	1,443	8	0%	98.8%
Stealthstation S8 Premium System	997	0	0%	96.1%
Stealthstation Treon Treatment Guidance System	961	0	0.4%	91.2%
Cart 9734056 S7 Staff Shrt 100-120v Intl	896	4	0%	95.1%
Rosa Surgical Device	710	0	0%	83%
Rosa Brain	675	0	0.1%	83.3%
Rosa One	556	0	0%	81.2%
Medtronic Navigation	549	69	6.7%	30.4%
Stealthstation I7 Integrated Navigation System	470	0	0%	95.8%
Open Spine Clamp Titanium	445	0	0%	99.8%
Stealthstation S7 Navigation	365	1	0%	95.4%
S7	339	0	0%	98.3%
Stealthstation S8 Em Ent System	301	0	0%	97.7%
Cart 9733856 S7 Staff Assembled 110v	292	0	0%	96.6%
Surgn Cart 9735665 Stealth S8 Premium	289	0	0%	98.3%
Stealthstation	273	0	0%	97.9%
S8 Premium	267	0	0%	97.8%
S7 Stealthstation Navigation System	253	0	0.4%	91.7%
Stealth S8 Premium	186	0	0.5%	98.9%
Stealthstation Tria Navigation System	173	0	0.6%	90.8%
Small Pointer	170	0	0%	100%
Patient Tracker 9734887xom Non-Invasive	166	7	0%	98.2%
Biopsy Guide	161	7	0.6%	97.5%
Xps System Navigated Blade	75	11	0%	97.4%
NavLock	17	90	0%	97%
Mazor X System	5	238	0.6%	81.3%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Navigation	29,421	68.7%
Medtronic Navigation Louisville	7,033	16.4%
Medtech	1,950	4.6%
Stryker Instruments-Kalamazoo	1,669	3.9%
Stryker Instruments-A Division Of Stryker	218	0.5%
Mako Surgical	214	0.5%
Mazor Robotics	151	0.4%
Stryker Leibinger Freiburg	80	0.2%
Integra Lifesciences Oh/USA	71	0.2%
Medtronic Xomed	67	0.2%
Medtronic Navigation Littleton	53	0.1%
Medtronic Neuromodulation	23	0.1%
Mdt Powered Surgical Solutions	22	0.1%
Zimmer	12	0%
Stryker Instruments	7	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 and report source

Event type

Death0.2%104

Injury6.9%2,956

Malfunction92.2%39,517

Other0.3%135

Not given0.3%128

Who filed

Manufacturer report99.5%42,640

Voluntary report0.2%76

User facility report0%0

Distributor report0%3

Not given0.3%121

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Imprecision	5,560	13%
Mechanical problema mechanical problem	4,655	10.9%
Application program freezes or fails to launch	3,172	7.4%
Human-device interface problem	3,018	7%
Device operates differently than expectedthe device behaved unexpectedly	2,774	6.5%
Communication or transmission problemthe device could not communicate or transmit	2,743	6.4%
Application program problem	2,700	6.3%
Device sensing problem	2,612	6.1%
Display or visual feedback problem	2,343	5.5%
Material integrity problema problem with the device material	2,252	5.3%
Computer software problema software problem	1,909	4.5%
Application interface becomes non-functional or program exits abnormally	1,899	4.4%
Incorrect, inadequate or imprecise result or readings	1,754	4.1%
Environmental compatibility problem	1,319	3.1%
Breakthe device broke	1,222	2.9%
Device stops intermittentlythe device stopped now and then	1,053	2.5%
Material deformation	948	2.2%
Output problem	762	1.8%
Connection problema connection problem	753	1.8%
Device displays incorrect message	670	1.6%

Questions about neurological stereotaxic instrument reports

What is product code HAW?

FDA's classification code for "Neurological stereotaxic instrument", class 2, reviewed by the neurology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

42,840 reports through August 2026, 1,803 of them in the latest 12 months.

Which brands appear most often?

StealthStation S8 system (10,817), Stealthstation S7 System (5,977), Stealthstation S7 (2,205), Fusion Navigation System (2,160) and Fusion Ent Navigation System (1,443). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.