| Brand Name | TMJ Bilateral Implants |
|---|
| Common Device Name | Joint, Temporomandibular, Implant |
|---|
| Manufacturer (Section D) |
| TMJ Solutions, LLC dba TMJ Concepts |
| 6059 king drive |
| ventura 93003 |
|
|---|
| Manufacturer (Section G) |
| TMJ Solutions, LLC dba TMJ Concepts |
| 6059 king drive |
|
| ventura 93003 |
|
|---|
| Manufacturer Contact |
|
elena
gehring
|
| boetzingerstr. 41 |
| freiburg D-791-11
|
|
GM
D-79111
|
|
+49()7614888208
|
|
|---|
| MDR Report Key | 50714622 |
|---|
| Report Number | 0002031049-2026-00101 |
|---|
| Device Sequence Number | 10696261 |
|---|
| Product Code |
LZD
|
| UDI-Device Identifier | 07613327626575 |
|---|
| UDI-Public | 07613327626575 |
|---|
| Combination Product (Y/N) | N |
|---|
| Initial Reporter State | CA |
|---|
| Initial Reporter Country | US |
|---|
| Number of Events Summarized | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Reporter Type |
Manufacturer
|
|---|
| Report Source |
Company Representative |
|---|
| Type of Report
| Initial |
|---|
| Report Date (Section B) |
09/10/2026 |
|---|
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
Yes
|
|---|
| Is this a Product Problem Report? |
No
|
|---|
| Device Catalogue Number | CHG020 |
|---|
| Device Lot Number | 2410091031 |
|---|
| Was Device Available for Evaluation? |
No
|
|---|
| Is the Reporter a Health Professional? |
No
|
|---|
| Initial Date Received by Manufacturer | 08/13/2026 |
|---|
| Initial Report FDA Received Date | 09/10/2026 |
|---|
| Was Device Evaluated by Manufacturer? (Y/N) |
No
|
|---|
| Is the Device Labeled for Single Use? (Y/N) |
Yes
|
|---|
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N) |
No
|
|---|
| Usage of Device |
Initial
|
|---|
| Patient Sequence Number | 1 |
|---|
| Outcome Attributed to Adverse Event |
Required Intervention;
|
| Patient Sex | Unknown |
|---|
|
|
