MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-14 for BLACKHAWK CERVICAL SPACER SYSTEM 05-090-21-1406 manufactured by Choicespine, Llc.
| Report Number | 3005819474-2019-00001 |
| MDR Report Key | 9586089 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-14 |
| Date of Report | 2019-09-12 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2019-09-12 |
| Device Manufacturer Date | 2018-11-21 |
| Date Added to Maude | 2020-01-14 |
| 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 | MRS KIM FINCH |
| Manufacturer Street | 400 ERIN DRIVE |
| Manufacturer City | KNOXVILLE TN 37919 |
| Manufacturer Country | US |
| Manufacturer Postal | 37919 |
| Manufacturer Phone | 8652463333 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLACKHAWK CERVICAL SPACER SYSTEM |
| Generic Name | INTERVERTEBRAL BODY FUSION DEVICES |
| Product Code | OVE |
| Date Received | 2020-01-14 |
| Model Number | 05-090-21-1406 |
| Catalog Number | 05-090-21-1406 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHOICESPINE, LLC |
| Manufacturer Address | 400 ERIN DRIVE KNOXVILLE TN 37919 US 37919 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |