MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-21 for SPIN THORACIC NAVIGATION SYSTEM/ALWAYS-ON TIP TRACKED FORCEPS SERRATED CUP SYS-4000 / INS-0372 manufactured by Veran Medical Technologies, Inc..
| Report Number | 3007222345-2019-00002 |
| MDR Report Key | 9215171 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-21 |
| Date of Report | 2019-10-21 |
| Date of Event | 2019-09-24 |
| Date Mfgr Received | 2019-09-24 |
| Device Manufacturer Date | 2018-11-12 |
| Date Added to Maude | 2019-10-21 |
| 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 | MRS. CHRISTINE HARDIN |
| Manufacturer Street | 1908 INNERBELT BUSINESS CENTER |
| Manufacturer City | ST. LOUIS MO 63114 |
| Manufacturer Country | US |
| Manufacturer Postal | 63114 |
| Manufacturer Phone | 3146598500 |
| Manufacturer G1 | VERAN MEDICAL TECHNOLOGIES, INC. |
| Manufacturer Street | 1908 INNERBELT BUSINESS CENTER |
| Manufacturer City | ST. LOUIS MO 63114 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIN THORACIC NAVIGATION SYSTEM/ALWAYS-ON TIP TRACKED FORCEPS SERRATED CUP |
| Generic Name | NAVIGATION SYSTEM/SERRATED FORCEPS |
| Product Code | JAK |
| Date Received | 2019-10-21 |
| Model Number | SYS-4000 / INS-0372 |
| Catalog Number | SYS-4000 / INS-0372 |
| Lot Number | 03610181112 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERAN MEDICAL TECHNOLOGIES, INC. |
| Manufacturer Address | 1908 INNERBELT BUSINESS CENTER ST. LOUIS MO 63114 US 63114 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-10-21 |