Spinal vertebral body replacement device: medical device reports filed with FDA

2,934 reports carry this product code, 2003–2026; 14 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.

2,934
reports with this product code: 0% of all MAUDE reports; 161
reports, 12 months to August 2026: 148 in the 12 months before; 48.9%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

Product code MQP is FDA's classification for "Spinal vertebral body replacement device" (orthopedic panel), a class 2 device. 2,934 medical device reports carry this product code, 0% of the MAUDE database, from April 2003 to August 2026.

161 reports arrived in the 12 months to August 2026, close to the 148 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 (49.6%), malfunction (48.9%) and other (0.7%). 14 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
T2 STRATOSPHERE Expandable Corpectomy System	301	43	0.3%	75.4%
Verte-Stack Spinal System	190	0	0.5%	63.2%
CAPSTONE Spinal System	37	26	0.3%	46.1%
Clydesdale Spinal System	26	33	0.4%	53.1%
Unknown Cage/Spacer	25	4	0%	6.4%
Unknown K2m Product	15	37	0%	38.3%
Collect No Qas Spine Anterior Stabilis	12	0	0%	2.2%
Crescent Spinal System	11	5	0.6%	82.3%
Unknown Screw/Rod Construct Accessories	6	0	0%	1%
Unknown_Spine_Product	6	24	0%	34.4%
Unk - Plates Spine	2	0	0%	3.9%
Unknown Screws	2	23	1.7%	21.9%
PRESTIGE Cervical Disc System	1	20	0.4%	27.6%
Ti 12-Point Nut-11mm	1	0	0%	18.4%

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	546	18.6%
Depuy Synthes Spine	186	6.3%
Nuvasive	118	4%
Globus Medical	107	3.6%
Depuy Spine	98	3.3%
K2m	77	2.6%
Medtronic Sofamor Danek	65	2.2%
Stryker Spine Bordeaux	33	1.1%
Zimmer Tmt	33	1.1%
Stryker Spine-France	30	1%
Stryker Spine-US	29	1%
Abbott Spine	22	0.7%
Mdt Sofamor Danek Puerto Rico Mfg	21	0.7%
Ldr M Dical	19	0.6%
Warsaw Orthopedic	19	0.6%

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

Death0.5%14

Injury49.6%1,456

Malfunction48.9%1,434

Other0.7%21

Not given0.3%9

Who filed

Manufacturer report95.9%2,813

Voluntary report2.4%71

User facility report0%0

Distributor report0.4%12

Not given1.3%38

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	680	23.2%
Migration or expulsion of device	288	9.8%
Migrationthe device moved from where it was placed	138	4.7%
Mechanical problema mechanical problem	131	4.5%
Fracturea broken bone	115	3.9%
Collapse	97	3.3%
Explanted	91	3.1%
Material deformation	89	3%
Device slipped	76	2.6%
Device dislodged or dislocated	72	2.5%
Insufficient device problem information	72	2.5%
Mechanics altered	69	2.4%
Device remains implanted	65	2.2%
Device operates differently than expectedthe device behaved unexpectedly	60	2%
Difficult to insertthe device was hard to insert	60	2%
Replace	59	2%
Detachment of device or device componentpart of the device came off	47	1.6%
Malposition of device	47	1.6%
Device, or device fragments remain in patient	38	1.3%
Detachment of device component	37	1.3%

Questions about spinal vertebral body replacement device reports

What is product code MQP?

FDA's classification code for "Spinal vertebral body replacement device", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,934 reports through August 2026, 161 of them in the latest 12 months.

Which brands appear most often?

T2 STRATOSPHERE Expandable Corpectomy System (301), Verte-Stack Spinal System (190), CAPSTONE Spinal System (37), Clydesdale Spinal System (26) and Unknown Cage/Spacer (25). 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.