Devices › Joint, temporomandibular, implant
Device brand name · Patient-fitted tmj reconstruction prosthesis
TMJ Bilateral Implants: medical device reports filed with FDA
261 reports name it, 2021–2026. Manufacturer given most often on reports: Tmj Solutions Tmj Concepts. Product code LZD.
- 261
- device reports naming the brand
- 0% of all MAUDE reports · about 56 a year
- 67
- reports, 12 months to August 2026
- 58 in the 12 months before
- 18.4%
- classified as malfunction
- 6.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
261 medical device reports received by FDA name the brand "TMJ Bilateral Implants" (patient-fitted tmj reconstruction prosthesis); the manufacturer given most often on reports is Tmj Solutions Tmj Concepts; received from November 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
67 reports arrived in the 12 months to August 2026, up 16% from 58 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 (81.6%) and malfunction (18.4%); across all joint, temporomandibular, implant reports (product code LZD) death is recorded in 0.2% and malfunction in 6.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device appears to trigger rejection (11.9%), device dislodged or dislocated (11.5%) and nonstandard device (11.1%). The patient problems coded most often are pain, joint dislocation and ankylosis. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,116 reports carrying product code LZD. 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 |
|---|---|---|---|
| Device appears to trigger rejection | 31 | 11.9% | 2% |
| Device dislodged or dislocated | 30 | 11.5% | 5.7% |
| Nonstandard device | 29 | 11.1% | 2.6% |
| Inadequacy of device shape and/or size | 16 | 6.1% | 3.3% |
| Fracturea broken bone | 12 | 4.6% | 3.2% |
| Malposition of device | 11 | 4.2% | 4.5% |
| Fitting problem | 8 | 3.1% | 1% |
| Patient-device incompatibilitythe device did not suit the patient | 7 | 2.7% | 3.1% |
| Positioning problem | 4 | 1.5% | 0.4% |
| Loosening of implant not related to bone-ingrowth | 3 | 1.1% | 1.3% |
| Loss of osseointegration | 3 | 1.1% | 0.6% |
| Patient device interaction problem | 3 | 1.1% | 2.3% |
| Component incompatible | 1 | 0.4% | 0% |
| Device handling problem | 1 | 0.4% | 0% |
| Device-device incompatibility | 1 | 0.4% | 0.1% |
| Inaccurate information | 1 | 0.4% | 0.1% |
| Material perforation | 1 | 0.4% | 0.1% |
| Product quality problem | 1 | 0.4% | 0.1% |
| Unintended movement | 1 | 0.4% | 0.1% |
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 |
|---|---|---|
| Painpain, site not specified | 51 | 19.5% |
| Joint dislocationa dislocated joint | 45 | 17.2% |
| Ankylosis | 28 | 10.7% |
| Swelling/ edema | 25 | 9.6% |
| Bacterial infectiona bacterial infection | 21 | 8% |
| Loss of range of motion | 12 | 4.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 9 | 3.4% |
| Difficulty chewing | 7 | 2.7% |
| Failure of implant | 7 | 2.7% |
| Hypersensitivity/allergic reaction | 7 | 2.7% |
| Itching sensation | 6 | 2.3% |
| Fluid discharge | 4 | 1.5% |
| Obstruction/occlusion | 4 | 1.5% |
| Hyperresponsive to stimuli | 3 | 1.1% |
| Implant pain | 3 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | TMJ Bilateral Implants | Product code LZD | All MAUDE reports |
|---|---|---|---|
| Reports | 261 | 3,116 | 26,136,888 |
| Share of that pool | — | 8.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 81.6% | 89.3% | 36.2% |
| Classified as malfunction | 18.4% | 6.3% | 62.3% |
| Filed by the manufacturer | 100% | 87.1% | 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 LZD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Total Temporomandibular Joint Replacement System | 212 | 0 | 0% |
| Unknown Screw | 1,222 | 156 | 0% |
| Unknown_Fro_Product | 192 | 7 | 0% |
| Ni | 32,939 | 1,587 | 1.8% |
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." 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 TMJ Bilateral Implants reports
How many FDA reports name TMJ Bilateral Implants?
261 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 67 in the latest 12 months.
What kinds of events are reported?
injury (81.6%) and malfunction (18.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device appears to trigger rejection (11.9%), device dislodged or dislocated (11.5%), nonstandard device (11.1%), inadequacy of device shape and/or size (6.1%) and fracture (4.6%). 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 TMJ Bilateral Implants 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.