MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-12 for CONVENTUS PHS SYSTEM 7768-1 manufactured by Conventus Orthopaedics, Inc..
| Report Number | 3008480376-2020-00010 |
| MDR Report Key | 9826304 |
| Report Source | OTHER |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-06-12 |
| Date Mfgr Received | 2019-06-12 |
| Date Added to Maude | 2020-03-12 |
| 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. KENNETH BLOCK |
| Manufacturer Street | 800 E. CAMPBELL ROAD SUITE 202 |
| Manufacturer City | RICHARDSON, TX |
| Manufacturer Country | US |
| Manufacturer Phone | 4809554 |
| Manufacturer G1 | CONVENTUS ORTHOPAEDICS, INC. |
| Manufacturer Street | 10200 73RD AVENUE NORTH SUITE 122 |
| Manufacturer City | MAPLE GROVE, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVENTUS PHS SYSTEM |
| Generic Name | NAIL, FIXATION, BONE |
| Product Code | JDS |
| Date Received | 2020-03-12 |
| Model Number | 7768-1 |
| Lot Number | 10255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVENTUS ORTHOPAEDICS, INC. |
| Manufacturer Address | 10200 73RD AVENUE NORTH SUITE 122 MAPLE GROVE, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-12 |