Device manufacturer, as written on reports

Medtronic Navigation Littleton: medical device reports filed with FDA

17,667 reports name it as the manufacturer of the device involved, 2012–2025.

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.

17,667
reports naming it as manufacturer: 0.1% of all MAUDE reports; 0
reports, 12 months to August 2026: 676 in the 12 months before; 98.2%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

17,667 medical device reports received by FDA give Medtronic Navigation Littleton as the manufacturer of the device involved, 0.1% of the MAUDE database, from July 2012 to July 2025. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, against 676 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 (98.2%) and injury (1.7%). 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
O-Arm 1000 Imaging System	Image-intensified fluoroscopic x-ray system, mobile	6,912	2	0%
O-Arm O2 Imaging System	Interventional fluoroscopic x-ray system	5,933	681	0.1%
O-Arm 1000 Imaging System 3rd Edition	Image-intensified fluoroscopic x-ray system, mobile	2,580	4	0%
O-Arm	Image-intensified fluoroscopic x-ray system, mobile	330	0	0%
O-Arm Imaging System	Image-intensified fluoroscopic x-ray system, mobile	329	44	1.5%
O2	Interventional fluoroscopic x-ray system	253	0	0.3%
Base Sys Bi70002000 O-Arm Sys O2	Interventional fluoroscopic x-ray system	224	0	0%
O2 O-Arm Imaging System	Interventional fluoroscopic x-ray system	116	0	0%
Medtronic Navigation	Neurological stereotaxic instrument	24	69	6.7%
Stealthstation S7 System	Neurological stereotaxic instrument	10	0	0.4%
StealthStation S8 system	Neurological stereotaxic instrument	6	1,368	0.1%
Cart 9734056 S7 Staff Shrt 100-120v Intl	Neurological stereotaxic instrument	4	4	0%
Fusion Navigation System	Neurological stereotaxic instrument	3	0	0%
StealthStation FlexENT	Ear, nose, and throat stereotaxic instrument	2	55	0%
Adapta	Pulse generator, permanent, implantable	1	279	7.4%
Biopsy Guide	Neurological stereotaxic instrument	1	7	0.6%
Fusion Compact	Ear, nose, and throat stereotaxic instrument	1	7	0%
Fusion Ent Navigation System	Neurological stereotaxic instrument	1	8	0%
NavLock	Orthopedic stereotaxic instrument	1	90	0%
Stealthstation S7	Neurological stereotaxic instrument	1	30	0.4%
Xps System Navigated Blade	Bur, ear, nose and throat	1	11	0%

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
OXO	Image-intensified fluoroscopic x-ray system, mobile	10,640	60.2%
OWB	Interventional fluoroscopic x-ray system	6,953	39.4%
HAW	Neurological stereotaxic instrument	53	0.3%
JAA	System, x-ray, fluoroscopic, image-intensified	10	0.1%
IZL	System, x-ray, mobile	4	0%
OLO	Orthopedic stereotaxic instrument	4	0%
PGW	Ear, nose, and throat stereotaxic instrument	4	0%
EQJ	Bur, ear, nose and throat	1	0%
JAK	System, x-ray, tomography, computed	1	0%
KKX	Drape, surgical, antimicrobial	1	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%7

Injury1.7%308

Malfunction98.2%17,350

Other0%0

Not given0%2

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 Littleton reports

How many FDA device reports name Medtronic Navigation Littleton as manufacturer?

17,667 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

O-Arm 1000 Imaging System (6,912), O-Arm O2 Imaging System (5,933), O-Arm 1000 Imaging System 3rd Edition (2,580), O-Arm (330) and O-Arm Imaging System (329).

Which device types does it report on?

image-intensified fluoroscopic x-ray system, mobile (60.2%), interventional fluoroscopic x-ray system (39.4%), neurological stereotaxic instrument (0.3%) and system, x-ray, fluoroscopic, image-intensified (0.1%).

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.