Bur, ear, nose and throat: medical device reports filed with FDA

2,731 reports carry this product code, 1994–2026; 6 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.

2,731
reports with this product code: 0% of all MAUDE reports; 217
reports, 12 months to August 2026: 486 in the 12 months before; 93.4%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code EQJ is FDA's classification for "Bur, ear, nose and throat" (ear, Nose, Throat panel), a class 1 device. 2,731 medical device reports carry this product code, 0% of the MAUDE database, from January 1994 to August 2026.

217 reports arrived in the 12 months to August 2026, down 55% from 486 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 (93.4%), injury (5.8%) and other (0.6%). 6 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
Xps Blade	579	71	0%	96.4%
Microdebrider Blades And Burs	412	53	0%	98.3%
Xps Bur - Unknown	371	46	0%	99.7%
Xps Bur	290	12	0%	92.8%
Xps System Navigated Blade	119	11	0%	97.4%
Arthrex	1	28	0%	75.9%

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 Xomed	2,151	78.8%
Medtronic Dominicana	91	3.3%
Mdt Puerto Rico Operations	53	1.9%
Stryker Ireland	38	1.4%
Conmed Linvatec	30	1.1%
Gyrus Acmi	30	1.1%
Mdt Powered Surgical Solutions	7	0.3%
Biomet Microfixation	5	0.2%
Medtronic Puerto Rico Operations	3	0.1%
Medtronic Navigation Littleton	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 and report source

Event type

Death0.1%3

Injury5.8%158

Malfunction93.4%2,551

Other0.6%16

Not given0.1%3

Who filed

Manufacturer report97.9%2,675

Voluntary report0.5%14

User facility report0%0

Distributor report0.1%3

Not given1.4%39

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,466	53.7%
Vibration	584	21.4%
Material fragmentation	329	12%
Material separation	161	5.9%
Physical resistance/sticking	120	4.4%
Mechanical jam	93	3.4%
Overheating of device	68	2.5%
Connection problema connection problem	31	1.1%
Noise, audible	22	0.8%
Detachment of device component	19	0.7%
Mechanical problema mechanical problem	19	0.7%
Heat	16	0.6%
Fracturea broken bone	14	0.5%
Failure to cut	13	0.5%
Component falling	10	0.4%
Device operates differently than expectedthe device behaved unexpectedly	10	0.4%
Material twisted/bent	10	0.4%
Tip breakage	10	0.4%
Device markings/labelling problema problem with the device markings or label	9	0.3%
Detachment of device or device componentpart of the device came off	8	0.3%

Questions about bur, ear, nose and throat reports

What is product code EQJ?

FDA's classification code for "Bur, ear, nose and throat", class 1, reviewed by the ear, Nose, Throat panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,731 reports through August 2026, 217 of them in the latest 12 months.

Which brands appear most often?

Xps Blade (579), Microdebrider Blades And Burs (412), Xps Bur - Unknown (371), Xps Bur (290) and Xps System Navigated Blade (119). 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.