Devices › Cement, bone, vertebroplasty
Device brand name · Cement bone vertebroplasty
Confidence Spinal Cmt Sys 11c: medical device reports filed with FDA
170 reports name it, 2013–2026. Manufacturer given most often on reports: Depuy Spine. Product code NDN.
- 170
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 14
- reports, 12 months to August 2026
- 24 in the 12 months before
- 85.9%
- classified as malfunction
- 74.9% across the product code
- 1.8%
- classified as death, as reported
- 3 reports · not verified by FDA
170 medical device reports received by FDA name the brand "Confidence Spinal Cmt Sys 11c" (cement bone vertebroplasty); the manufacturer given most often on reports is Depuy Spine; received from February 2013 to March 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
14 reports arrived in the 12 months to August 2026, down 42% from 24 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 (85.9%), injury (12.4%) and death (1.8%); across all cement, bone, vertebroplasty reports (product code NDN) death is recorded in 1.9% and malfunction in 74.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration or expulsion of device (23.5%), chemical problem (11.8%) and leak/splash (10.6%). The patient problems coded most often are death, foreign body in patient and arrhythmia. 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 4,843 reports carrying product code NDN. 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 |
|---|---|---|---|
| Migration or expulsion of device | 40 | 23.5% | 11.3% |
| Chemical problem | 20 | 11.8% | 4% |
| Leak/splashthe device leaked | 18 | 10.6% | 12.5% |
| Failure to eject | 14 | 8.2% | 4.3% |
| Breakthe device broke | 13 | 7.6% | 5% |
| Fluid/blood leak | 11 | 6.5% | 6.3% |
| Device-device incompatibility | 5 | 2.9% | 0.6% |
| Pressure problem | 3 | 1.8% | 0.1% |
| Decrease in pressure | 2 | 1.2% | 0.2% |
| Device damaged prior to usethe device was damaged before use | 2 | 1.2% | 0.1% |
| Entrapment of device | 2 | 1.2% | 0.5% |
| Filling problem | 2 | 1.2% | 0.3% |
| Mechanical problema mechanical problem | 2 | 1.2% | 0.1% |
| No flow | 2 | 1.2% | 0.5% |
| Collapse | 1 | 0.6% | 0% |
| Connection problema connection problem | 1 | 0.6% | 0% |
| Crackthe device cracked | 1 | 0.6% | 0.1% |
| Device contaminated during manufacture or shipping | 1 | 0.6% | 0% |
| Disassembly | 1 | 0.6% | 0% |
| Inaccurate information | 1 | 0.6% | 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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 4 | 2.4% |
| Foreign body in patientpart of a device left in the patient | 3 | 1.8% |
| Arrhythmia | 2 | 1.2% |
| Cardiac arrestthe heart stopped | 2 | 1.2% |
| Device embedded in tissue or plaque | 2 | 1.2% |
| Injurya physical injury | 2 | 1.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.6% |
| Blood loss | 1 | 0.6% |
| Diminished pulse pressure | 1 | 0.6% |
| Fluid discharge | 1 | 0.6% |
| Hemorrhage/blood loss/bleeding | 1 | 0.6% |
| Hypersensitivity/allergic reaction | 1 | 0.6% |
| No patient involvement | 1 | 0.6% |
| Nonunion/delayed-union bone fracture | 1 | 0.6% |
| Not applicable | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Confidence Spinal Cmt Sys 11c | Product code NDN | All MAUDE reports |
|---|---|---|---|
| Reports | 170 | 4,843 | 26,136,888 |
| Share of that pool | — | 3.5% | 0% |
| Classified as death, per 1,000 reports | 18 | 19 | 9 |
| Classified as injury | 12.4% | 22.4% | 36.2% |
| Classified as malfunction | 85.9% | 74.9% | 62.3% |
| Filed by the manufacturer | 100% | 98.1% | 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 NDN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Kyphx Hv-R Bone Cement | 916 | 7 | 3.4% |
| Vertecem V+ Cement Kit | 701 | 98 | 0.1% |
| KYPHON HV-R Bone Cement | 314 | 110 | 0.3% |
| Confidence Kit No Needles | 175 | 8 | 5.1% |
| KYPHON Xpede Bone Cement | 168 | 38 | 3% |
| Synflate Balloon/Medium- Sterile | 173 | 66 | 0% |
| Unknown_InstrumentstIre_Product | 1,475 | 123 | 0% |
| Unknown Instruments Product | 400 | 23 | 0.8% |
| Simplex P-Japanese Twin Pack | 312 | 1 | 10.6% |
| Stryker | 559 | 5 | 1.3% |
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 Confidence Spinal Cmt Sys 11c reports
How many FDA reports name Confidence Spinal Cmt Sys 11c?
170 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 14 in the latest 12 months.
What kinds of events are reported?
malfunction (85.9%), injury (12.4%) and death (1.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration or expulsion of device (23.5%), chemical problem (11.8%), leak/splash (10.6%), failure to eject (8.2%) and break (7.6%). 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 Confidence Spinal Cmt Sys 11c 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.