Orthosis, spinal pedicle fixation: medical device reports filed with FDA

3,992 reports carry this product code, 1997–2026; 23 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.

3,992
reports with this product code: 0% of all MAUDE reports; 51
reports, 12 months to August 2026: 69 in the 12 months before; 38.1%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

Product code MNI is FDA's classification for "Orthosis, spinal pedicle fixation" (orthopedic panel), a class 2 device. 3,992 medical device reports carry this product code, 0% of the MAUDE database, from June 1997 to August 2026.

51 reports arrived in the 12 months to August 2026, down 26% from 69 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 (60.2%), malfunction (38.1%) and other (1.1%). 23 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
Ti Locking Screw	49	0	0%	4.3%
Everest Spinal System	37	0	1%	25.1%
Pathfinder	36	0	0%	66.8%
Xia 3 Titanium Blocker	28	7	0%	56.2%
Tsrh Spinal System	25	0	0.4%	23.4%
Unknown_Spine_Product	25	24	0%	34.4%
Unknown Screw/Rod Construct Accessories	12	0	0%	1%
UNK - Constructs: Plate/Screws	11	9	0%	0.2%
Unknown Screws	10	23	1.7%	21.9%
Ti 12-Point Nut-11mm	9	0	0%	18.4%
Blocker	8	0	0%	90.6%
Ti Matrix Locking Cap	7	0	1.2%	15.3%
Ti Nut 11mm Width Across Flats	7	0	0%	4.3%
Unknown Rods	7	9	1.1%	9.3%
Expedium Verse	6	127	0%	69.7%
Reform Pedicle Screw System	2	12	0%	75%
UNK - Constructs: DHS/DCS	2	17	1.9%	0.7%
Cd Horizon	1	38	0.3%	50.5%
Creo	1	48	0.2%	92.5%
Matneu Scr 1 5 Self-Drill L4 Tan 4u I/C	1	41	0%	95%
Ti Collar With Grooves	1	0	0%	17.5%
Unk - Screws	1	0	0%	7.8%
Unknown Mono/Polyaxial Screws	1	0	0%	10%

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	589	14.8%
Medos International S Rl Ch	278	7%
Stryker Spine-France	197	4.9%
K2m	139	3.5%
Ebi	135	3.4%
Depuy Synthes Spine	125	3.1%
Stryker Spine Bordeaux	96	2.4%
Depuy Spine	92	2.3%
Synthes Brandywine	82	2.1%
Abbott Spine	49	1.2%
Zimmer Spine	32	0.8%
Nuvasive	31	0.8%
Synthes Mezzovico	27	0.7%
Warsaw Orthopedic	26	0.7%
Warsaw Orthopedics	22	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

Death0.4%17

Injury60.2%2,402

Malfunction38.1%1,519

Other1.1%43

Not given0.3%11

Who filed

Manufacturer report98%3,914

Voluntary report1%39

User facility report0%0

Distributor report0.4%14

Not given0.6%25

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,034	25.9%
Insufficient device problem information	316	7.9%
Fracturea broken bone	242	6.1%
Device operates differently than expectedthe device behaved unexpectedly	232	5.8%
Explanted	211	5.3%
Device slipped	204	5.1%
Detachment of device component	151	3.8%
Migration or expulsion of device	144	3.6%
Device dislodged or dislocated	138	3.5%
Material separation	106	2.7%
Loose or intermittent connection	104	2.6%
Replace	92	2.3%
Loose	75	1.9%
Material integrity problema problem with the device material	68	1.7%
Migrationthe device moved from where it was placed	61	1.5%
Disassembly	57	1.4%
Mechanical problema mechanical problem	57	1.4%
Detachment of device or device componentpart of the device came off	56	1.4%
Device-device incompatibility	56	1.4%
Material deformation	47	1.2%

Questions about orthosis, spinal pedicle fixation reports

What is product code MNI?

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

How many reports carry this code?

3,992 reports through August 2026, 51 of them in the latest 12 months.

Which brands appear most often?

Ti Locking Screw (49), Everest Spinal System (37), Pathfinder (36), Xia 3 Titanium Blocker (28) and Tsrh Spinal System (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.