| Brand Name | MOSS |
| Common Device Name | DRIVER, PROSTHESIS |
| Manufacturer (Section D) |
| Depuy Spine Inc |
| 325 paramount drive |
| raynham MA 02767 |
|
| Manufacturer Contact |
|
elba
bello
|
| 325 paramount drive |
| raynham, MA 02767
|
|
+1(908)386-3534
|
|
| MDR Report Key | 50741399 |
| Report Number | 1526439-2026-01427 |
| Device Sequence Number | 12897173 |
| Product Code |
HWR
|
| UDI-Device Identifier | 10705034199030 |
| UDI-Public | (01)10705034199030 |
| Combination Product (Y/N) | N |
| Initial Reporter Country | US |
| PMA/510(K) Number | Exempt |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
Foreign,Health Professional,Company Representative,Distributor |
| Initial Reporter Occupation |
Other Health Care Professional
|
| Type of Report
| Initial,Followup |
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
No
|
| Is this a Product Problem Report? |
Yes
|
| Operator of Device |
Health Professional
|
| Device Catalogue Number | 279712600 |
| Was Device Available for Evaluation? |
No
|
| Is the Reporter a Health Professional? |
No
|
| Initial Date Received by Manufacturer | 08/19/2026 |
| Supplement Date Received by Manufacturer | 09/14/2026
|
| Initial Report FDA Received Date | 09/11/2026 |
| Supplement Report FDA Received Date | 09/15/2026
|
| Was Device Evaluated by Manufacturer? (Y/N) |
No
|
| Is the Device Labeled for Single Use? (Y/N) |
No
|
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N) |
No
|
| Usage of Device |
Unknown
|
| Patient Sequence Number | 1 |
| Patient Sex | Unknown |
|
|