Device brand name · Absorbable perirectal spacer
SpaceOAR System: medical device reports filed with FDA
909 reports name it, 2017–2026. Manufacturer given most often on reports: Boston Scientific. Product code OVB.
- 909
- device reports naming the brand
- 0% of all MAUDE reports · about 97 a year
- 100
- reports, 12 months to August 2026
- 106 in the 12 months before
- 60%
- classified as malfunction
- 63.4% across the product code
- 0.2%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 909 reports that name the brand "SpaceOAR System" (absorbable perirectal spacer), received between March 2017 and August 2026; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
100 reports arrived in the 12 months to August 2026, close to the 106 of 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 (60%), injury (39.8%) and death (0.2%); across all hydrogel spacer reports (product code OVB) death is recorded in 0.5% and malfunction in 63.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are positioning problem (63.9%), malposition of device (6.5%) and migration (2.5%). The patient problems coded most often are pain, fistula and discomfort. 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
Who filed the report
Grey bar: all 2,123 reports carrying product code OVB. 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 |
|---|---|---|---|
| Positioning problem | 581 | 63.9% | 61.6% |
| Malposition of device | 59 | 6.5% | 10.8% |
| Migrationthe device moved from where it was placed | 23 | 2.5% | 2.9% |
| Material integrity problema problem with the device material | 20 | 2.2% | 3.1% |
| Obstruction of flow | 15 | 1.7% | 2% |
| Device contamination with chemical or other material | 13 | 1.4% | 1.2% |
| Defective devicethe device was defective | 9 | 1% | 1.5% |
| Inadequacy of device shape and/or size | 5 | 0.6% | 0.9% |
| Material deformation | 3 | 0.3% | 0.5% |
| Improper chemical reaction | 2 | 0.2% | 0.1% |
| Precipitate in device or device ingredient | 2 | 0.2% | 0% |
| Device contaminated during manufacture or shipping | 1 | 0.1% | 0% |
| Device ingredient or reagent problem | 1 | 0.1% | 0.2% |
| Failure to cut | 1 | 0.1% | 0% |
| Failure to deliverthe device did not deliver the dose or item | 1 | 0.1% | 0% |
| Fluid/blood leak | 1 | 0.1% | 0.1% |
| Incomplete or inadequate connection | 1 | 0.1% | 0% |
| Insufficient device problem information | 1 | 0.1% | 0.3% |
| Leak/splashthe device leaked | 1 | 0.1% | 0% |
| Nonstandard device | 1 | 0.1% | 0% |
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 | 183 | 20.1% |
| Fistula | 105 | 11.6% |
| Discomfortdiscomfort | 101 | 11.1% |
| Hemorrhage/blood loss/bleeding | 90 | 9.9% |
| Abscessa collection of pus | 89 | 9.8% |
| Ulcer | 79 | 8.7% |
| Inflammationinflammation | 77 | 8.5% |
| Fluid discharge | 60 | 6.6% |
| Urinary retentionbeing unable to empty the bladder | 51 | 5.6% |
| Fever | 46 | 5.1% |
| Perforation | 40 | 4.4% |
| Constipationconstipation | 39 | 4.3% |
| Hypersensitivity/allergic reaction | 28 | 3.1% |
| Urinary frequency / polyuria | 18 | 2% |
| Diarrhea | 15 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | SpaceOAR System | Product code OVB | All MAUDE reports |
|---|---|---|---|
| Reports | 909 | 2,123 | 26,136,888 |
| Share of that pool | — | 42.8% | 0% |
| Classified as death, per 1,000 reports | 2 | 5 | 9 |
| Classified as injury | 39.8% | 36.1% | 36.2% |
| Classified as malfunction | 60% | 63.4% | 62.3% |
| Filed by the manufacturer | 99.9% | 98.4% | 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 OVB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| SpaceOAR VUE System | 815 | 45 | 0.4% |
| SpaceOAR VUE? System - 10mL | 273 | 178 | 1.1% |
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 SpaceOAR System reports
How many FDA reports name SpaceOAR System?
909 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 100 in the latest 12 months.
What kinds of events are reported?
malfunction (60%), injury (39.8%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
positioning problem (63.9%), malposition of device (6.5%), migration (2.5%), material integrity problem (2.2%) and obstruction of flow (1.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that SpaceOAR 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.