Devices › Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Device brand name · Filler recombinant human bone morphogenetic protein collagen scaffold with met
Infuse Bone Graft: medical device reports filed with FDA
12,081 reports name it, 2003–2026. Manufacturer given most often on reports: Medtronic Sofamor Danek USA. Product code NEK.
- 12,081
- device reports naming the brand
- 0% of all MAUDE reports · about 518 a year
- 36
- reports, 12 months to August 2026
- 40 in the 12 months before
- 0.4%
- classified as malfunction
- 0.7% across the product code
- 0.3%
- classified as death, as reported
- 38 reports · not verified by FDA
FDA's MAUDE database holds 12,081 reports that name the brand "Infuse Bone Graft" (filler recombinant human bone morphogenetic protein collagen scaffold with met), received between March 2003 and July 2026; the manufacturer given most often on reports is Medtronic Sofamor Danek USA. Spellings of one product vary from report to report.
36 reports arrived in the 12 months to August 2026, down 10% from 40 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 (99.2%), malfunction (0.4%) and death (0.3%); across all filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction reports (product code NEK) death is recorded in 0.3% and malfunction in 0.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (4.3%), device remains implanted (0.8%) and off-label use (0.4%). The patient problems coded most often are injury, pain and extraskeletal ossification. 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 13,040 reports carrying product code NEK. 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 |
|---|---|---|---|
| Insufficient device problem information | 516 | 4.3% | 7.7% |
| Device remains implanted | 92 | 0.8% | 0.9% |
| Off-label use | 47 | 0.4% | 0.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 40 | 0.3% | 0.7% |
| Migration or expulsion of device | 32 | 0.3% | 0.4% |
| Explanted | 31 | 0.3% | 0.4% |
| Osseointegration problem | 22 | 0.2% | 0.2% |
| Patient-device incompatibilitythe device did not suit the patient | 13 | 0.1% | 0.3% |
| Replace | 9 | 0.1% | 0.2% |
| Other (for use when an appropriate device code cannot be identified) | 7 | 0.1% | 0.1% |
| Loss of osseointegration | 6 | 0% | 0% |
| Failure to osseointegrate | 5 | 0% | 0.1% |
| Improper or incorrect procedure or method | 5 | 0% | 0.1% |
| Malposition of device | 5 | 0% | 0.1% |
| Breakthe device broke | 4 | 0% | 0.2% |
| Collapse | 4 | 0% | 0% |
| Device dislodged or dislocated | 4 | 0% | 0% |
| Material fragmentation | 4 | 0% | 0% |
| Aspiration issue | 3 | 0% | 0% |
| Device slipped | 3 | 0% | 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 |
|---|---|---|
| Injurya physical injury | 5,719 | 47.3% |
| Painpain, site not specified | 4,168 | 34.5% |
| Extraskeletal ossification | 1,528 | 12.6% |
| Neuropathy | 1,174 | 9.7% |
| Numbnessnumbness | 1,006 | 8.3% |
| Stenosis | 843 | 7% |
| Ambulation or postural difficulties | 767 | 6.3% |
| Nerve damage | 754 | 6.2% |
| Weakness | 727 | 6% |
| Tingling | 588 | 4.9% |
| Swellingswelling | 537 | 4.4% |
| Inflammationinflammation | 518 | 4.3% |
| Neck painneck pain | 500 | 4.1% |
| Muscle spasm(s) | 361 | 3% |
| Loss of range of motion | 344 | 2.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Infuse Bone Graft | Product code NEK | All MAUDE reports |
|---|---|---|---|
| Reports | 12,081 | 13,040 | 26,136,888 |
| Share of that pool | — | 92.6% | 0% |
| Classified as death, per 1,000 reports | 3 | 3 | 9 |
| Classified as injury | 99.2% | 98.5% | 36.2% |
| Classified as malfunction | 0.4% | 0.7% | 62.3% |
| Filed by the manufacturer | 99.8% | 94.8% | 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 NEK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Medtronic Infuse Bone Graft Or Rhbmp2 | 483 | 0 | 0% |
| Verte-Stack Spinal System | 212 | 0 | 0.5% |
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 Infuse Bone Graft reports
How many FDA reports name Infuse Bone Graft?
12,081 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 36 in the latest 12 months.
What kinds of events are reported?
injury (99.2%), malfunction (0.4%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (4.3%), device remains implanted (0.8%), off-label use (0.4%), device operates differently than expected (0.3%) and migration or expulsion of device (0.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Infuse Bone Graft 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.