Intervertebral fusion device with bone graft, lumbar: medical device reports filed with FDA

9,238 reports carry this product code, 1996–2026; 21 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.

9,238
reports with this product code: 0% of all MAUDE reports; 695
reports, 12 months to August 2026: 865 in the 12 months before; 63.3%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code MAX is FDA's classification for "Intervertebral fusion device with bone graft, lumbar" (orthopedic panel), a class 2 device. 9,238 medical device reports carry this product code, 0% of the MAUDE database, from January 1996 to August 2026.

695 reports arrived in the 12 months to August 2026, down 20% from 865 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 (63.3%), injury (35.6%) and other (0.5%). 21 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
Catalyft PL Expandable Interbody System	376	95	0%	74.9%
ELEVATE Spinal System	322	46	0%	88.9%
CAPSTONE Spinal System	321	26	0.3%	46.1%
Crescent Spinal System	305	5	0.6%	82.3%
Clydesdale Spinal System	234	33	0.4%	53.1%
CLYDESDALE PTC Spinal System	222	5	0%	77.9%
Pivox Oblique Lateral Spinal System	221	5	0%	80%
T-Pal Spacer Applicator Inner Shaft	187	0	0%	88.6%
T-Pal Spacer Applicator Knob	139	0	0%	86.5%
T-Pal Spacer Applicator Handle	93	0	0%	86%
Unknown Cage/Spacer	29	4	0%	6.4%
Unknown_Spine_Product	29	24	0%	34.4%
Orthopedic Manual Surgical Instrument	19	0	0.2%	85.9%
Collect No Qas Spine Anterior Stabilis	7	0	0%	2.2%
Verte-Stack Spinal System	4	0	0.5%	63.2%
Divergence Anterior Cervical Fusion System	3	30	0%	93%
Ti Matrix Locking Cap	3	0	1.2%	15.3%
Locking Screw	2	3	0%	17.8%
Unknown Implant	2	1,454	0%	1.2%
Onyx	1	69	13.4%	12%
Tsrh Spinal System	1	0	0.4%	23.4%

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 Sofamor Danek USA	815	8.8%
Mdt Sofamor Danek Puerto Rico Mfg	484	5.2%
Nuvasive	450	4.9%
Warsaw Orthopedics	433	4.7%
Stryker Spine-US	375	4.1%
K2m	283	3.1%
Depuy Spine	230	2.5%
Stryker Spine-France	220	2.4%
Medtronic Sofamor Danek	198	2.1%
Medos International S Rl Ch	185	2%
Synthes Hagendorf	177	1.9%
Zimmer Biomet Spine	172	1.9%
Zimmer Spine	155	1.7%
Medtronic Navigation	131	1.4%
Ldr M Dical	119	1.3%

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

Death0.3%30

Injury35.6%3,289

Malfunction63.3%5,844

Other0.5%45

Not given0.3%30

Who filed

Manufacturer report97.1%8,969

Voluntary report2%181

User facility report0%0

Distributor report0.2%20

Not given0.7%68

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	2,650	28.7%
Migrationthe device moved from where it was placed	784	8.5%
Fracturea broken bone	783	8.5%
Migration or expulsion of device	624	6.8%
Mechanical problema mechanical problem	528	5.7%
Device-device incompatibility	442	4.8%
Collapse	208	2.3%
Material deformation	203	2.2%
Device dislodged or dislocated	190	2.1%
Insufficient device problem information	185	2%
Material integrity problema problem with the device material	180	1.9%
Device operates differently than expectedthe device behaved unexpectedly	177	1.9%
Mechanical jam	166	1.8%
Compatibility problem	136	1.5%
Crackthe device cracked	130	1.4%
Detachment of device component	129	1.4%
Mechanics altered	120	1.3%
Difficult to insertthe device was hard to insert	116	1.3%
Malposition of device	116	1.3%
Material fragmentation	103	1.1%

Questions about intervertebral fusion device with bone graft, lumbar reports

What is product code MAX?

FDA's classification code for "Intervertebral fusion device with bone graft, 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?

9,238 reports through August 2026, 695 of them in the latest 12 months.

Which brands appear most often?

Catalyft PL Expandable Interbody System (376), ELEVATE Spinal System (322), CAPSTONE Spinal System (321), Crescent Spinal System (305) and Clydesdale Spinal System (234). 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.