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Device brand name · Prosthesis spinous process spacer/plate

Superion Indirect Decompression System: medical device reports filed with FDA

1,789 reports name it, 2018–2026. Manufacturer given most often on reports: Boston Scientific Neuromodulation. Product code NQO.

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.

1,789
device reports naming the brand: 0% of all MAUDE reports · about 229 a year; 592
reports, 12 months to August 2026: 96 in the 12 months before; 69.7%
classified as malfunction: 51.6% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 1,789 reports that name the brand "Superion Indirect Decompression System" (prosthesis spinous process spacer/plate), received between September 2018 and August 2026; the manufacturer given most often on reports is Boston Scientific Neuromodulation. Spellings of one product vary from report to report.

592 reports arrived in the 12 months to August 2026, up 517% from 96 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 (69.7%) and injury (30.3%); across all prosthesis, spinous process spacer/plate reports (product code NQO) death is recorded in 0.2% and malfunction in 51.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are material integrity problem (64.3%), difficult to open or close (9.6%) and migration (9.3%). The patient problems coded most often are pain, bone fracture(s) and vertebral fracture. 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

Death0%0

Injury30.3%542

Malfunction69.7%1,247

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%1,789

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 2,909 reports carrying product code NQO. 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
Material integrity problema problem with the device material	1,150	64.3%	43.8%
Difficult to open or close	172	9.6%	6.2%
Migrationthe device moved from where it was placed	166	9.3%	7.6%
Lack of effect	56	3.1%	3.1%
Device dislodged or dislocated	47	2.6%	3.3%
Material twisted/bent	43	2.4%	1.7%
Defective devicethe device was defective	12	0.7%	0.5%
Malposition of device	12	0.7%	0.9%
Nonstandard device	7	0.4%	0.3%
Mechanical problema mechanical problem	5	0.3%	0.3%
Device fell	2	0.1%	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
Painpain, site not specified	206	11.5%
Bone fracture(s)	65	3.6%
Vertebral fracture	54	3%
Discomfortdiscomfort	33	1.8%
Inadequate pain relief	33	1.8%
Therapeutic effects, unexpected	32	1.8%
Falla fall	17	1%
Numbnessnumbness	13	0.7%
Implant pain	9	0.5%
Complaint, ill-defined	6	0.3%
Fluid discharge	5	0.3%
Muscle weakness/atrophy	5	0.3%
Swelling/ edema	5	0.3%
Injurya physical injury	4	0.2%
Appropriate clinical signs, symptoms and conditions term/code not available	3	0.2%

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

In context

Measure	Superion Indirect Decompression System	Product code NQO	All MAUDE reports
Reports	1,789	2,909	26,136,888
Share of that pool	—	61.5%	0%
Classified as death, per 1,000 reports	0	2	9
Classified as injury	30.3%	45%	36.2%
Classified as malfunction	69.7%	51.6%	62.3%
Filed by the manufacturer	100%	99.3%	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 NQO

Brand	Reports	Latest 12 months	Classified as death
X-Stop Ipd System	397	0	0.8%
Superion Interspinous Spacer	242	18	0.4%
Driver	214	27	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 Superion Indirect Decompression System reports

How many FDA reports name Superion Indirect Decompression System?

1,789 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 592 in the latest 12 months.

What kinds of events are reported?

malfunction (69.7%) and injury (30.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material integrity problem (64.3%), difficult to open or close (9.6%), migration (9.3%), lack of effect (3.1%) and device dislodged or dislocated (2.6%). 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 Superion Indirect Decompression 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.