MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-07 for VSP SYSTEM Fibula Cutting Guide with Implant Placement manufactured by 3d Systems.
| Report Number | 1724955-2019-00002 |
| MDR Report Key | 9293209 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-11-07 |
| Date of Report | 2019-11-05 |
| Date of Event | 2019-10-17 |
| Date Mfgr Received | 2019-10-17 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2019-11-07 |
| 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 SCOTT BREWER |
| Manufacturer Street | 5381 SOUTH ALKIRE CIRCLE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7206431001 |
| Manufacturer G1 | 3D SYSTEMS |
| Manufacturer Street | 5381 SOUTH ALKIRE CIRCLE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80127 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VSP SYSTEM |
| Generic Name | VSP RECONSTRUCTION |
| Product Code | DZJ |
| Date Received | 2019-11-07 |
| Model Number | Fibula Cutting Guide with Implant Placement |
| Lot Number | 127258 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3D SYSTEMS |
| Manufacturer Address | 5381 SOUTH ALKIRE CIRCLE LITTLETON CO 80127 US 80127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-07 |