MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-02 for BIOINDUCTIVE IMPLANT W/ARTH DEL LRG 4566 manufactured by Rotation Medical, Inc..
| Report Number | 3009351468-2020-00004 |
| MDR Report Key | 9656964 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-02 |
| Date of Report | 2020-03-08 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-08-27 |
| Date Added to Maude | 2020-02-02 |
| 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 | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| Manufacturer G1 | ROTATION MEDICAL, INC. |
| Manufacturer Street | 15350 25TH AVE. NO., SUITE 100 |
| Manufacturer City | PLYMOUTH MN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOINDUCTIVE IMPLANT W/ARTH DEL LRG |
| Generic Name | MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON |
| Product Code | OWY |
| Date Received | 2020-02-02 |
| Catalog Number | 4566 |
| Lot Number | A7362 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROTATION MEDICAL, INC. |
| Manufacturer Address | 15350 25TH AVE. NO., SUITE 100 PLYMOUTH MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-02 |