Devices › Sacroiliac joint fixation
Device brand name · Orthopedic rod
Ifuse Implant System: medical device reports filed with FDA
1,275 reports name it, 2011–2025. Manufacturer given most often on reports: Si-Bone. Product code OUR.
- 1,275
- device reports naming the brand
- 0% of all MAUDE reports · about 85 a year
- 0
- reports, 12 months to August 2026
- 3 in the 12 months before
- 0.1%
- classified as malfunction
- 1.1% across the product code
- 0.2%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 1,275 reports that name the brand "Ifuse Implant System" (orthopedic rod), received between August 2011 and July 2025; the manufacturer given most often on reports is Si-Bone. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 3 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 injury (97.1%), other (2%) and death (0.2%); across all sacroiliac joint fixation reports (product code OUR) death is recorded in 0.4% and malfunction in 1.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are malposition of device (51.7%), loss of osseointegration (7.7%) and inadequacy of device shape and/or size (6.1%). The patient problems coded most often are arthralgia, pain and undesired nerve stimulation. 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 1,408 reports carrying product code OUR. 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 |
|---|---|---|---|
| Malposition of device | 659 | 51.7% | 47.9% |
| Loss of osseointegration | 98 | 7.7% | 7.1% |
| Inadequacy of device shape and/or size | 78 | 6.1% | 5.8% |
| Insufficient device problem information | 70 | 5.5% | 5.6% |
| Positioning problem | 34 | 2.7% | 2.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 27 | 2.1% | 2.1% |
| Device slipped | 27 | 2.1% | 2% |
| Failure to osseointegrate | 25 | 2% | 1.8% |
| Difficult to removethe device was hard to remove | 20 | 1.6% | 1.6% |
| Improper or incorrect procedure or method | 14 | 1.1% | 1.5% |
| Breakthe device broke | 8 | 0.6% | 1.2% |
| Device dislodged or dislocated | 8 | 0.6% | 0.6% |
| Device handling problem | 7 | 0.5% | 0.5% |
| Migration or expulsion of device | 6 | 0.5% | 1% |
| Fitting problem | 5 | 0.4% | 0.5% |
| Device damaged by another device | 4 | 0.3% | 0.3% |
| Entrapment of device | 3 | 0.2% | 0.4% |
| Fracturea broken bone | 3 | 0.2% | 0.5% |
| Loose or intermittent connection | 3 | 0.2% | 0.3% |
| Bent | 2 | 0.2% | 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 |
|---|---|---|
| Arthralgiajoint pain | 436 | 34.2% |
| Painpain, site not specified | 420 | 32.9% |
| Undesired nerve stimulation | 415 | 32.5% |
| Joint disorder | 81 | 6.4% |
| Nerve proximity NOS (not otherwise specified) | 72 | 5.6% |
| Numbnessnumbness | 24 | 1.9% |
| Bone fracture(s) | 22 | 1.7% |
| Falla fall | 21 | 1.6% |
| Hematomaa collection of blood under the skin or in tissue | 16 | 1.3% |
| Physical entrapment | 16 | 1.3% |
| Inadequate pain relief | 12 | 0.9% |
| Bacterial infectiona bacterial infection | 11 | 0.9% |
| Hemorrhage/blood loss/bleeding | 11 | 0.9% |
| Hypersensitivity/allergic reaction | 8 | 0.6% |
| Cellulitisa skin infection | 7 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ifuse Implant System | Product code OUR | All MAUDE reports |
|---|---|---|---|
| Reports | 1,275 | 1,408 | 26,136,888 |
| Share of that pool | — | 90.6% | 0% |
| Classified as death, per 1,000 reports | 2 | 4 | 9 |
| Classified as injury | 97.1% | 96.1% | 36.2% |
| Classified as malfunction | 0.1% | 1.1% | 62.3% |
| Filed by the manufacturer | 99.8% | 98.9% | 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."
Questions about Ifuse Implant System reports
How many FDA reports name Ifuse Implant System?
1,275 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (97.1%), other (2%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
malposition of device (51.7%), loss of osseointegration (7.7%), inadequacy of device shape and/or size (6.1%), insufficient device problem information (5.5%) and positioning problem (2.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ifuse Implant 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.