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

4,393 reports carry this product code, 1996–2026; 24 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.

4,393
reports with this product code: 0% of all MAUDE reports; 68
reports, 12 months to August 2026: 97 in the 12 months before; 35%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code MNH is FDA's classification for "Orthosis, spondylolisthesis spinal fixation" (orthopedic panel), a class 2 device. 4,393 medical device reports carry this product code, 0% of the MAUDE database, from October 1996 to August 2026.

68 reports arrived in the 12 months to August 2026, down 30% from 97 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 (64.2%), malfunction (35%) and other (0.6%). 24 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
Creo	330	48	0.2%	92.5%
Unknown Screw/Rod Construct Accessories	207	0	0%	1%
Ti Collar With Grooves	179	0	0%	17.5%
Ti Nut 11mm Width Across Flats	151	0	0%	4.3%
Xia 3 Titanium Blocker	81	7	0%	56.2%
Unknown Screws	77	23	1.7%	21.9%
Unknown Mono/Polyaxial Screws	70	0	0%	10%
Ti Locking Screw	30	0	0%	4.3%
Unknown Rods	15	9	1.1%	9.3%
Verse Correction Key	14	3	0%	62.2%
Mis Single Inner Setscw	6	9	0.5%	28.7%
Unknown Cage/Spacer	6	4	0%	6.4%
Unknown_Spine_Product	6	24	0%	34.4%
Ti Matrix Locking Cap	4	0	1.2%	15.3%
Cd Horizon Solera 5 5/6 0	3	131	0%	97.7%
UNK - Constructs: Plate/Screws	3	9	0%	0.2%
Closure Top	2	27	0%	61.8%
Single-Inner Setscrew	2	19	0%	30.4%
UNK - Constructs: DHS/DCS	2	17	1.9%	0.7%
Unk - Plates Spine	2	0	0%	3.9%
Reform Pedicle Screw System	1	12	0%	75%
Tsrh Spinal System	1	0	0.4%	23.4%
Unk - Constructs Pfna	1	0	1.2%	2.4%
Unk - Screws	1	0	0%	7.8%

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	614	14%
Globus Medical	534	12.2%
Synthes Brandywine	279	6.4%
Zimmer Biomet Spine	248	5.6%
Oberdorf Synthes Produktions	247	5.6%
Stryker Spine-France	226	5.1%
Depuy Spine	110	2.5%
Synthes USA	98	2.2%
Stryker Spine Bordeaux	70	1.6%
K2m	41	0.9%
Ebi	28	0.6%
Alphatec Spine	17	0.4%
Stryker Spine-US	17	0.4%
Wrights Lane Synthes USA Products	17	0.4%
Zimmer Spine	17	0.4%

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%2

Injury64.2%2,821

Malfunction35%1,538

Other0.6%27

Not given0.1%5

Who filed

Manufacturer report99.3%4,363

Voluntary report0.5%21

User facility report0%0

Distributor report0%0

Not given0.2%9

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	936	21.3%
Insufficient device problem information	289	6.6%
Device slipped	277	6.3%
Fracturea broken bone	218	5%
Migrationthe device moved from where it was placed	192	4.4%
Loose or intermittent connection	183	4.2%
Device operates differently than expectedthe device behaved unexpectedly	159	3.6%
Migration or expulsion of device	141	3.2%
Device dislodged or dislocated	138	3.1%
Detachment of device component	117	2.7%
Explanted	96	2.2%
Mechanical problema mechanical problem	95	2.2%
Material integrity problema problem with the device material	86	2%
Detachment of device or device componentpart of the device came off	85	1.9%
Unintended movement	80	1.8%
Material deformation	76	1.7%
Material separation	57	1.3%
Device-device incompatibility	56	1.3%
Replace	49	1.1%
Patient device interaction problem	48	1.1%

Questions about orthosis, spondylolisthesis spinal fixation reports

What is product code MNH?

FDA's classification code for "Orthosis, spondylolisthesis spinal 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?

4,393 reports through August 2026, 68 of them in the latest 12 months.

Which brands appear most often?

Creo (330), Unknown Screw/Rod Construct Accessories (207), Ti Collar With Grooves (179), Ti Nut 11mm Width Across Flats (151) and Xia 3 Titanium Blocker (81). 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.