| Brand Name | TRUMATCH GRAFT CAGE-LONG BONE >5CM TO 10CM/STERILE |
|---|
| Common Device Name | Plate, fixation, bone |
|---|
| Manufacturer (Section D) |
| Wrights Lane Synthes USA Products LLC |
| 1302 wrights lane east |
| west chester PA 19380 |
|
|---|
| Manufacturer (Section G) |
| Wilson Drive Manufacturing |
| 1230 wilson drive |
|
| west chester PA |
|
|---|
| Manufacturer Contact |
|
elba
bello
|
| 1302 wrights lane east |
| west chester, PA 19380
|
|
+1(908)386-3534
|
|
|---|
| MDR Report Key | 50856379 |
|---|
| Report Number | 2939274-2026-00001 |
|---|
| Device Sequence Number | 18625931 |
|---|
| Product Code |
HRS
|
| UDI-Device Identifier | 10886982262479 |
|---|
| Combination Product (Y/N) | N |
|---|
| Initial Reporter Country | US |
|---|
| PMA/510(K) Number | K180821 |
|---|
| Number of Events Summarized | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Reporter Type |
Manufacturer
|
|---|
| Report Source |
Health Professional,Company Representative |
|---|
| Initial Reporter Occupation |
Other Health Care Professional
|
|---|
| Type of Report
| Initial |
|---|
| 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 | SD900.501S |
|---|
| Was Device Available for Evaluation? |
No
|
|---|
| Is the Reporter a Health Professional? |
Yes
|
|---|
| Initial Date Received by Manufacturer | 06/10/2026 |
|---|
| Initial Report FDA Received Date | 09/22/2026 |
|---|
| 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 |
|---|
|
|
