Devices › Prosthesis, intervertebral disc
Device brand name · Prosthesis intervertebral disc
Bryan Cervical Disc System: medical device reports filed with FDA
261 reports name it, 2010–2019. Manufacturer given most often on reports: Warsaw Orthopedics. Product code MJO.
- 261
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 27.2%
- classified as malfunction
- 17.2% across the product code
- 0.4%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 261 reports that name the brand "Bryan Cervical Disc System" (prosthesis intervertebral disc), received between April 2010 and September 2019; the manufacturer given most often on reports is Warsaw Orthopedics. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (71.3%), malfunction (27.2%) and death (0.4%); across all prosthesis, intervertebral disc reports (product code MJO) death is recorded in 0.2% and malfunction in 17.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration or expulsion of device (10.7%), failure to cut (6.9%) and mechanical problem (4.2%). The patient problems coded most often are extraskeletal ossification, pain and neck pain. 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."
Reports by month, five years
No report naming Bryan Cervical Disc System was received in the five years to August 2026; the latest was received in September 2019.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 6,183 reports carrying product code MJO. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Migration or expulsion of device | 28 | 10.7% | 11.3% |
| Failure to cut | 18 | 6.9% | 0.3% |
| Mechanical problema mechanical problem | 11 | 4.2% | 1.2% |
| Insufficient device problem information | 9 | 3.4% | 14.2% |
| Breakthe device broke | 8 | 3.1% | 2.7% |
| Device inoperablethe device could not be used | 8 | 3.1% | 0.1% |
| Device dislodged or dislocated | 3 | 1.1% | 3% |
| Malposition of device | 3 | 1.1% | 3.3% |
| Collapse | 2 | 0.8% | 1.6% |
| Device operational issue | 2 | 0.8% | 0.1% |
| Loose or intermittent connection | 2 | 0.8% | 0.5% |
| Mechanical jam | 2 | 0.8% | 0.4% |
| Peeled/delaminated | 2 | 0.8% | 0% |
| Crackthe device cracked | 1 | 0.4% | 0% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.4% | 0% |
| Device slipped | 1 | 0.4% | 2% |
| Difficult to insertthe device was hard to insert | 1 | 0.4% | 0.4% |
| Failure to adhere or bond | 1 | 0.4% | 0.2% |
| Failure to disconnect | 1 | 0.4% | 0% |
| Improper flow or infusion | 1 | 0.4% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Extraskeletal ossification | 44 | 16.9% |
| Painpain, site not specified | 31 | 11.9% |
| Neck painneck pain | 21 | 8% |
| Loss of range of motion | 10 | 3.8% |
| Numbnessnumbness | 10 | 3.8% |
| Neuropathy | 9 | 3.4% |
| Dysphagia/ odynophagia | 8 | 3.1% |
| Stenosis | 8 | 3.1% |
| Tingling | 6 | 2.3% |
| Weakness | 5 | 1.9% |
| Cerebrospinal fluid leakage | 3 | 1.1% |
| Neurological deficit/dysfunction | 3 | 1.1% |
| Chest tightness/pressure | 2 | 0.8% |
| Cyst(s) | 2 | 0.8% |
| Discomfortdiscomfort | 2 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bryan Cervical Disc System | Product code MJO | All MAUDE reports |
|---|---|---|---|
| Reports | 261 | 6,183 | 26,136,888 |
| Share of that pool | — | 4.2% | 0% |
| Classified as death, per 1,000 reports | 4 | 2 | 9 |
| Classified as injury | 71.3% | 82.2% | 36.2% |
| Classified as malfunction | 27.2% | 17.2% | 62.3% |
| Filed by the manufacturer | 100% | 95.7% | 94.9% |
Shares are of reports, not of devices in use. 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."
Other brands with product code MJO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| M6-C | 452 | 31 | 0% |
| PRESTIGE Cervical Disc System | 275 | 20 | 0.4% |
| Charite Artificial Disc Size Unknown | 161 | 0 | 1.2% |
| Collect No Qas Spine Anterior Stabilis | 269 | 0 | 0% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Bryan Cervical Disc System reports
How many FDA reports name Bryan Cervical Disc System?
261 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (71.3%), malfunction (27.2%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration or expulsion of device (10.7%), failure to cut (6.9%), mechanical problem (4.2%), insufficient device problem information (3.4%) and break (3.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Bryan Cervical Disc System was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.