Prosthesis, intervertebral disc: medical device reports filed with FDA

6,183 reports carry this product code, 2003–2026; 5 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.

6,183
reports with this product code: 0% of all MAUDE reports; 303
reports, 12 months to August 2026: 254 in the 12 months before; 17.2%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code MJO is FDA's classification for "Prosthesis, intervertebral disc" (unknown panel), a class 3 device. 6,183 medical device reports carry this product code, 0% of the MAUDE database, from August 2003 to August 2026.

303 reports arrived in the 12 months to August 2026, up 19% from 254 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 (82.2%), malfunction (17.2%) and death (0.2%). 5 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
M6-C	452	31	0%	6.6%
PRESTIGE Cervical Disc System	274	20	0.4%	27.6%
Bryan Cervical Disc System	261	0	0.4%	27.2%
Charite Artificial Disc Size Unknown	161	0	1.2%	0%
Collect No Qas Spine Anterior Stabilis	16	0	0%	2.2%

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 Brandywine	1,361	22%
Ldr M Dical	758	12.3%
Depuy Spine	547	8.8%
Warsaw Orthopedics	347	5.6%
Synthes USA	343	5.5%
Nuvasive	231	3.7%
Aesculap	145	2.3%
Warsaw Orthopedic	122	2%
Medtronic Sofamor Danek	96	1.6%
Globus Medical	50	0.8%
Synthes Hagendorf	45	0.7%
Medtronic Sofamor Danek USA	13	0.2%
Synthes	12	0.2%

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%11

Injury82.2%5,081

Malfunction17.2%1,063

Other0.1%8

Not given0.3%20

Who filed

Manufacturer report95.7%5,918

Voluntary report2.7%168

User facility report0%0

Distributor report1.3%81

Not given0.3%16

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	878	14.2%
Migration or expulsion of device	699	11.3%
Migrationthe device moved from where it was placed	393	6.4%
Device remains implanted	349	5.6%
Patient-device incompatibilitythe device did not suit the patient	251	4.1%
Explanted	212	3.4%
Malposition of device	204	3.3%
Detachment of device or device componentpart of the device came off	203	3.3%
Device dislodged or dislocated	186	3%
Breakthe device broke	164	2.7%
Patient device interaction problem	159	2.6%
Device slipped	124	2%
Collapse	101	1.6%
Device operates differently than expectedthe device behaved unexpectedly	100	1.6%
Fracturea broken bone	94	1.5%
Positioning problem	90	1.5%
Expulsion	77	1.2%
Mechanical problema mechanical problem	75	1.2%
Unintended movement	71	1.1%
Inadequacy of device shape and/or size	70	1.1%

Questions about prosthesis, intervertebral disc reports

What is product code MJO?

FDA's classification code for "Prosthesis, intervertebral disc", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

6,183 reports through August 2026, 303 of them in the latest 12 months.

Which brands appear most often?

M6-C (452), PRESTIGE Cervical Disc System (274), Bryan Cervical Disc System (261), Charite Artificial Disc Size Unknown (161) and Collect No Qas Spine Anterior Stabilis (16). 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.