Appliance, fixation, spinal intervertebral body: medical device reports filed with FDA

10,584 reports carry this product code, 1993–2026; 30 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.

10,584
reports with this product code: 0% of all MAUDE reports; 341
reports, 12 months to August 2026: 287 in the 12 months before; 42.4%
classified as malfunction: 62.3% across all reports; 0.6%
classified as death, as reported: 0.9% across all reports

Product code KWQ is FDA's classification for "Appliance, fixation, spinal intervertebral body" (orthopedic panel), a class 2 device. 10,584 medical device reports carry this product code, 0% of the MAUDE database, from December 1993 to August 2026.

341 reports arrived in the 12 months to August 2026, up 19% from 287 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 injury (54.1%), malfunction (42.4%) and other (2.3%). 30 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
ATLANTIS Anterior Cervical Plate System	339	18	1.6%	31.5%
CD HORIZON Spinal System	250	634	0.3%	56.8%
Venture Anterior Cervical Plate System	153	4	0.5%	42.6%
Resonate	135	7	0.9%	69.6%
Zevo Anterior Cervical Plate System	132	13	0.6%	54.1%
Collect No Qas Spine Anterior Stabilis	124	0	0%	2.2%
Unknown K2m Product	89	37	0%	38.3%
Tsrh Spinal Fixation System	81	0	0%	2.6%
Unknown_Spine_Product	71	24	0%	34.4%
Synthes	49	0	0.6%	36.4%
Incompass	47	0	0%	57.1%
Tsrh Spinal System	45	0	0.4%	23.4%
Pivox Oblique Lateral Spinal System	29	5	0%	80%
Stardrive Screwdriver Shaft T8 105mm	26	43	0%	96.4%
Screw	23	0	0%	14.8%
Vertex Reconstruction System	20	9	0.3%	51.1%
Insignia	17	0	1.3%	43.9%
Unknown Screws	12	23	1.7%	21.9%
Ni	10	1,587	1.8%	29.5%
Expedium	9	235	0%	42.4%
Codman	8	0	1.6%	57.9%
Ti Nut 11mm Width Across Flats	8	0	0%	4.3%
Unknown Implant	6	1,454	0%	1.2%
Unknown Rods	5	9	1.1%	9.3%
Ti Collar With Grooves	4	0	0%	17.5%
Apollo	3	141	1.8%	84.1%
Verse Correction Key	3	3	0%	62.2%
Quantum	2	35	0.5%	66.7%
Unknown Product	2	0	2.7%	44.3%
Verte-Stack Spinal System	2	0	0.5%	63.2%

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
Synthes USA	1,093	10.3%
K2m	613	5.8%
Warsaw Orthopedic	447	4.2%
Stryker Spine Bordeaux	388	3.7%
Medtronic Sofamor Danek	362	3.4%
Depuy Spine	325	3.1%
Warsaw Orthopedics	316	3%
Medos International S Rl Ch	289	2.7%
Nuvasive	281	2.7%
Stryker Spine-France	271	2.6%
Alphatec Spine	252	2.4%
Zimmer Biomet Spine	247	2.3%
Zimmer Spine	246	2.3%
Globus Medical	203	1.9%
Abbott Spine	201	1.9%

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

Death0.6%59

Injury54.1%5,725

Malfunction42.4%4,492

Other2.3%247

Not given0.6%61

Who filed

Manufacturer report95%10,058

Voluntary report2.5%262

User facility report0%0

Distributor report0.9%96

Not given1.6%168

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	2,203	20.8%
Explanted	1,239	11.7%
Fracturea broken bone	893	8.4%
Migration or expulsion of device	709	6.7%
Replace	641	6.1%
Device dislodged or dislocated	575	5.4%
Migrationthe device moved from where it was placed	501	4.7%
Device slipped	435	4.1%
Insufficient device problem information	430	4.1%
Loose	355	3.4%
Device remains implanted	352	3.3%
Detachment of device component	319	3%
Device operates differently than expectedthe device behaved unexpectedly	276	2.6%
Material integrity problema problem with the device material	198	1.9%
Detachment of device or device componentpart of the device came off	195	1.8%
Material separation	189	1.8%
Malposition of device	188	1.8%
Mechanical problema mechanical problem	184	1.7%
Difficult to removethe device was hard to remove	183	1.7%
Difficult to insertthe device was hard to insert	143	1.4%

Questions about appliance, fixation, spinal intervertebral body reports

What is product code KWQ?

FDA's classification code for "Appliance, fixation, spinal intervertebral body", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

10,584 reports through August 2026, 341 of them in the latest 12 months.

Which brands appear most often?

ATLANTIS Anterior Cervical Plate System (339), CD HORIZON Spinal System (250), Venture Anterior Cervical Plate System (153), Resonate (135) and Zevo Anterior Cervical Plate System (132). 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.