MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-01-21 for VALEO AND VALEO II manufactured by Sintx Technologies (formerly Amedica Corp).
| Report Number | 3005032068-2019-00001 |
| MDR Report Key | 9611914 |
| Report Source | LITERATURE |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JASON PARBERRY |
| Manufacturer Street | 1885 W 2100 SOUTH |
| Manufacturer City | SALT LAKE CITY, |
| Manufacturer G1 | SINTX TECHNOLOGIES |
| Manufacturer Street | 1885 W 2100 SOUTH |
| Manufacturer City | SALT LAKE CITY UT 84121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84121 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALEO AND VALEO II |
| Generic Name | VALEO AND VALEO II IBFDS |
| Product Code | ODP |
| Date Received | 2020-01-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP) |
| Manufacturer Address | 1885 WEST 2100 SOUTH SALT LAKE CITY UT 84121 US 84121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-21 |