Thoracolumbosacral pedicle screw system: medical device reports filed with FDA

24,738 reports carry this product code, 2002–2026; 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.

24,738
reports with this product code: 0.1% of all MAUDE reports; 1,324
reports, 12 months to August 2026: 1,241 in the 12 months before; 41.2%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code NKB is FDA's classification for "Thoracolumbosacral pedicle screw system" (orthopedic panel), a class 2 device. 24,738 medical device reports carry this product code, 0.1% of the MAUDE database, from March 2002 to August 2026.

1,324 reports arrived in the 12 months to August 2026, close to the 1,241 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 (58.1%), malfunction (41.2%) and death (0.3%). 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
CD HORIZON Spinal System	2,137	634	0.3%	56.8%
Ti Matrix Locking Cap	471	0	1.2%	15.3%
Blocker	439	0	0%	90.6%
Nuvasive Reline System	435	8	1.5%	71.2%
Single-Inner Setscrew	431	19	0%	30.4%
Closure Top	427	27	0%	61.8%
CD HORIZON SOLERA VOYAGER Spinal System	385	216	0.1%	76.1%
5 5 Exp Verse Unitized Set Scr	288	11	0%	18.1%
Open Implant Closure Top	277	0	0%	65.7%
Unknown Mono/Polyaxial Screws	269	0	0%	10%
CD HORIZON SOLERA Spinal System	259	68	0%	62.2%
Verse Correction Key	254	3	0%	62.2%
Xia 3 Titanium Blocker	194	7	0%	56.2%
Mis Single Inner Setscw	192	9	0.5%	28.7%
Unknown_Spine_Product	190	24	0%	34.4%
Ti 12-Point Nut-11mm	157	0	0%	18.4%
Expedium	138	235	0%	42.4%
CD Horizon Ballast Spinal System	131	20	0%	62.2%
Ti Pangea Locking Cap	124	0	0%	8.6%
Everest Spinal System	122	0	1%	25.1%
Invictus Spinal Fixation System	119	140	0%	69.6%
Unknown K2m Product	77	37	0%	38.3%
Unknown Screws	77	23	1.7%	21.9%
Unknown Rods	66	9	1.1%	9.3%
Unk - Screws	62	0	0%	7.8%
Expedium Verse	55	127	0%	69.7%
Creo	51	48	0.2%	92.5%
Unknown Screw/Rod Construct Accessories	43	0	0%	1%
Invictus	40	0	0%	74.3%
Tsrh Spinal System	24	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
Medos International S Rl Ch	3,624	14.6%
Zimmer Biomet Spine	2,147	8.7%
Depuy Synthes Spine	1,810	7.3%
Synthes USA	1,661	6.7%
Synthes Brandywine	1,482	6%
Zimmer Spine	1,339	5.4%
Mdt Sofamor Danek Puerto Rico Mfg	1,193	4.8%
Stryker Spine-US	970	3.9%
Medtronic Sofamor Danek USA	842	3.4%
Nuvasive	796	3.2%
K2m	690	2.8%
Stryker Spine Bordeaux	599	2.4%
Depuy Spine	588	2.4%
Synthes	546	2.2%
Warsaw Orthopedics	446	1.8%

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%86

Injury58.1%14,366

Malfunction41.2%10,181

Other0.2%56

Not given0.2%49

Who filed

Manufacturer report99.2%24,538

Voluntary report0.4%103

User facility report0%0

Distributor report0.1%33

Not given0.3%64

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	5,294	21.4%
Fracturea broken bone	2,001	8.1%
Migrationthe device moved from where it was placed	1,513	6.1%
Device slipped	1,477	6%
Material deformation	1,356	5.5%
Migration or expulsion of device	1,135	4.6%
Loose or intermittent connection	1,126	4.6%
Device dislodged or dislocated	1,083	4.4%
Insufficient device problem information	793	3.2%
Detachment of device component	703	2.8%
Detachment of device or device componentpart of the device came off	698	2.8%
Loosening of implant not related to bone-ingrowth	690	2.8%
Device operates differently than expectedthe device behaved unexpectedly	560	2.3%
Material twisted/bent	507	2%
Mechanical problema mechanical problem	384	1.6%
Unintended movement	360	1.5%
Device-device incompatibility	315	1.3%
Difficult to removethe device was hard to remove	313	1.3%
Torn material	305	1.2%
Malposition of device	276	1.1%

Questions about thoracolumbosacral pedicle screw system reports

What is product code NKB?

FDA's classification code for "Thoracolumbosacral pedicle screw system", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

24,738 reports through August 2026, 1,324 of them in the latest 12 months.

Which brands appear most often?

CD HORIZON Spinal System (2,137), Ti Matrix Locking Cap (471), Blocker (439), Nuvasive Reline System (435) and Single-Inner Setscrew (431). 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.