Intervertebral fusion device with integrated fixation, lumbar: medical device reports filed with FDA

1,270 reports carry this product code, 2009–2026; 3 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.

1,270
reports with this product code: 0% of all MAUDE reports; 49
reports, 12 months to August 2026: 52 in the 12 months before; 36.4%
classified as malfunction: 62.3% across all reports; 0.9%
classified as death, as reported: 0.9% across all reports

Product code OVD is FDA's classification for "Intervertebral fusion device with integrated fixation, lumbar" (orthopedic panel), a class 2 device. 1,270 medical device reports carry this product code, 0% of the MAUDE database, from February 2009 to August 2026.

49 reports arrived in the 12 months to August 2026, close to the 52 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 injury (62.3%), malfunction (36.4%) and death (0.9%). 3 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
Unknown Cage/Spacer	168	4	0%	6.4%
Pivox Oblique Lateral Spinal System	5	5	0%	80%
Unk - Plates Spine	3	0	0%	3.9%

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
Medos International S Rl Ch	146	11.5%
Ldr M Dical	89	7%
Nuvasive	76	6%
Alphatec Spine	74	5.8%
K2m	44	3.5%
Depuy Spine	33	2.6%
Stryker Spine-US	22	1.7%
Globus Medical	13	1%
Stryker Spine-France	12	0.9%
Zimmer Biomet Spine	8	0.6%
Medacta International	4	0.3%
Medtronic Sofamor Danek	2	0.2%
Abiomed	1	0.1%
Synthes USA	1	0.1%

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

Death0.9%11

Injury62.3%791

Malfunction36.4%462

Other0.2%2

Not given0.3%4

Who filed

Manufacturer report98.2%1,247

Voluntary report1%13

User facility report0%0

Distributor report0.4%5

Not given0.4%5

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	199	15.7%
Migrationthe device moved from where it was placed	121	9.5%
Fracturea broken bone	83	6.5%
Migration or expulsion of device	38	3%
Detachment of device or device componentpart of the device came off	34	2.7%
Patient device interaction problem	34	2.7%
Material separation	27	2.1%
Malposition of device	24	1.9%
Device dislodged or dislocated	22	1.7%
Mechanical problema mechanical problem	20	1.6%
Device-device incompatibility	19	1.5%
Crackthe device cracked	18	1.4%
Positioning problem	18	1.4%
Unintended movement	18	1.4%
Compatibility problem	16	1.3%
Difficult to insertthe device was hard to insert	16	1.3%
Insufficient device problem information	16	1.3%
Material deformation	16	1.3%
Bent	12	0.9%
Material integrity problema problem with the device material	12	0.9%

Questions about intervertebral fusion device with integrated fixation, lumbar reports

What is product code OVD?

FDA's classification code for "Intervertebral fusion device with integrated fixation, lumbar", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,270 reports through August 2026, 49 of them in the latest 12 months.

Which brands appear most often?

Unknown Cage/Spacer (168), Pivox Oblique Lateral Spinal System (5) and Unk - Plates Spine (3). 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.