| Brand Name | Torx Threaded Peg, 18mm |
| Common Device Name | Torx Threaded Peg, 18mm |
| Manufacturer (Section D) |
| TriMed, Inc. |
| 27533 avenue hopkins |
| santa clarita CA 91355 |
|
| Manufacturer (Section G) |
| TriMed, Inc. |
| 27533 avenue hopkins |
|
| santa clarita CA 91355 |
|
| Manufacturer Contact |
|
megan
rissler
|
| 27533 avenue hopkins |
| santa clarita, CA 91355
|
|
+1(661)255-7406
|
|
| MDR Report Key | 50809169 |
| Report Number | 2031009-2026-00014 |
| Device Sequence Number | 15589289 |
| Product Code |
JDS
|
| UDI-Device Identifier | 00842188108372 |
| UDI-Public | 00842188108372 |
| Combination Product (Y/N) | N |
| Initial Reporter State | SC |
| Initial Reporter Country | US |
| PMA/510(K) Number | K951302 |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Device Implanted Year | 2026 |
| Serviced by Third Party (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
Company Representative |
| Initial Reporter Occupation |
Non-Healthcare Professional
|
| Type of Report
| Initial |
| Report Date (Section B) |
09/17/2026 |
| 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
|
| Operator of Device |
Health Professional
|
| Device Catalogue Number | TPEG-18 |
| Was Device Available for Evaluation? |
No
|
| Is the Reporter a Health Professional? |
No
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 08/20/2026 |
| Initial Report FDA Received Date | 09/17/2026 |
| 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 |
| Patient Sex | Unknown |
|
|