Implant, fixation device, spinal: medical device reports filed with FDA

910 reports carry this product code, 1992–2024; 7 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.

910
reports with this product code: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 1 in the 12 months before; 22.5%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

Product code JDN is FDA's classification for "Implant, fixation device, spinal" (orthopedic panel), a class 2 device. 910 medical device reports carry this product code, 0% of the MAUDE database, from June 1992 to October 2024.

0 reports arrived in the 12 months to August 2026, against 1 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 (67.8%), malfunction (22.5%) and other (7.3%). 7 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
Tsrh Spinal Fixation System	33	0	0%	2.6%
Synthes	16	0	0.6%	36.4%
Tsrh Spinal System	6	0	0.4%	23.4%
ATLANTIS Anterior Cervical Plate System	4	18	1.6%	31.5%
Ni	2	1,587	1.8%	29.5%
Ti 12-Point Nut-11mm	2	0	0%	18.4%
Mesh	1	2	0.4%	2.6%

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
Depuy Spine	57	6.3%
Synthes USA	34	3.7%
Warsaw Orthopedic	32	3.5%
Synthes	31	3.4%
Depuy Orthopaedics	20	2.2%
Stryker Spine Bordeaux	17	1.9%
Abbott Spine	8	0.9%
Nuvasive	8	0.9%
Zimmer Tmt	5	0.5%
Smith & Nephew Orthopaedic Div	4	0.4%
Aesculap	3	0.3%
Ebi	3	0.3%
Medtronic Sofamor Danek	3	0.3%
Smith & Nephew Orthopaedics	3	0.3%
Stryker Spine-US	3	0.3%

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

Death0.7%6

Injury67.8%617

Malfunction22.5%205

Other7.3%66

Not given1.8%16

Who filed

Manufacturer report76.9%700

Voluntary report11.1%101

User facility report0%0

Distributor report0.4%4

Not given11.5%105

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

Device problems coded

Device problem (FDA code)	Reports	Share
Explanted	269	29.6%
Breakthe device broke	217	23.8%
Replace	111	12.2%
Device remains implanted	85	9.3%
Fracturea broken bone	71	7.8%
Loose	62	6.8%
Insufficient device problem information	43	4.7%
Component(s), broken	36	4%
Implant, removal of	35	3.8%
Device slipped	24	2.6%
Migration or expulsion of device	24	2.6%
Dislodged	22	2.4%
Material separation	22	2.4%
Device issuea problem with the device	17	1.9%
Other (for use when an appropriate device code cannot be identified)	16	1.8%
Detachment of device component	14	1.5%
Implant breakage or physical damage	12	1.3%
Device operates differently than expectedthe device behaved unexpectedly	11	1.2%
Device dislodged or dislocated	10	1.1%
Device, or device fragments remain in patient	9	1%

Questions about implant, fixation device, spinal reports

What is product code JDN?

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

How many reports carry this code?

910 reports through August 2026, 0 of them in the latest 12 months.

Which brands appear most often?

Tsrh Spinal Fixation System (33), Synthes (16), Tsrh Spinal System (6), ATLANTIS Anterior Cervical Plate System (4) and Ni (2). 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.