Cement, bone, vertebroplasty: medical device reports filed with FDA

4,843 reports carry this product code, 2004–2026; 11 brands with a page.

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.

4,843
reports with this product code: 0% of all MAUDE reports; 615
reports, 12 months to August 2026: 603 in the 12 months before; 74.9%
classified as malfunction: 62.3% across all reports; 1.9%
classified as death, as reported: 0.9% across all reports

Product code NDN is FDA's classification for "Cement, bone, vertebroplasty" (orthopedic panel), a class 2 device. 4,843 medical device reports carry this product code, 0% of the MAUDE database, from February 2004 to August 2026.

615 reports arrived in the 12 months to August 2026, close to the 603 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 (74.9%), injury (22.4%) and death (1.9%). 11 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Kyphx Hv-R Bone Cement	913	7	3.4%	65.3%
Vertecem V+ Cement Kit	693	98	0.1%	91.7%
KYPHON HV-R Bone Cement	314	110	0.3%	91.1%
Confidence Kit No Needles	175	8	5.1%	92%
Confidence Spinal Cmt Sys 11c	170	14	1.8%	85.9%
KYPHON Xpede Bone Cement	168	38	3%	84.5%
Synflate Balloon/Medium- Sterile	164	66	0%	99.4%
Unknown_InstrumentstIre_Product	7	123	0%	97.4%
Unknown Instruments Product	4	23	0.8%	80.5%
Simplex P-Japanese Twin Pack	1	1	10.6%	71.5%
Stryker	1	5	1.3%	46.3%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Spine	572	11.8%
Medtronic Sofamor Danek USA	491	10.1%
Medtronic Sofamor Danek	388	8%
Depuy Spine	232	4.8%
Medos International S Rl Ch	197	4.1%
Depuy Synthes Spine	187	3.9%
Synthes Selzach	99	2%
Stryker Instruments-Kalamazoo	9	0.2%
Synthes	4	0.1%
Wrights Lane Synthes USA Products	4	0.1%
Depuy Cmw - 9610921	2	0%
Stryker Instruments	2	0%
Arthrocare	1	0%
Carefusion 303	1	0%
Stryker Orthopaedics Limerick	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1.9%94

Injury22.4%1,086

Malfunction74.9%3,629

Other0.5%26

Not given0.2%8

Who filed

Manufacturer report98.1%4,752

Voluntary report1.3%62

User facility report0%0

Distributor report0%0

Not given0.6%29

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Leak/splashthe device leaked	604	12.5%
Migration or expulsion of device	547	11.3%
Improper chemical reaction	398	8.2%
Coagulation in device or device ingredient	354	7.3%
Fluid/blood leak	305	6.3%
Inflation problem	279	5.8%
Breakthe device broke	244	5%
Material integrity problema problem with the device material	220	4.5%
Failure to eject	207	4.3%
Chemical problem	195	4%
Compatibility problem	143	3%
Migrationthe device moved from where it was placed	106	2.2%
Insufficient device problem information	97	2%
Device operates differently than expectedthe device behaved unexpectedly	93	1.9%
Activation, positioning or separation problem	57	1.2%
Product quality problem	57	1.2%
Device remains implanted	48	1%
Fracturea broken bone	40	0.8%
Device-device incompatibility	28	0.6%
Packaging problem	28	0.6%

Questions about cement, bone, vertebroplasty reports

What is product code NDN?

FDA's classification code for "Cement, bone, vertebroplasty", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

4,843 reports through August 2026, 615 of them in the latest 12 months.

Which brands appear most often?

Kyphx Hv-R Bone Cement (913), Vertecem V+ Cement Kit (693), KYPHON HV-R Bone Cement (314), Confidence Kit No Needles (175) and Confidence Spinal Cmt Sys 11c (170). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.