MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-09-03 for MAGEC SPINAL BRACING AND DISTRACTION SYSTEM RA002-5555SL manufactured by Nuvasive Specialized Orthopedics, Inc.
| Report Number | 3006179046-2019-00151 |
| MDR Report Key | 8956962 |
| Report Source | FOREIGN |
| Date Received | 2019-09-03 |
| Date of Report | 2019-11-20 |
| Date Mfgr Received | 2019-11-20 |
| Device Manufacturer Date | 2015-12-11 |
| Date Added to Maude | 2019-09-03 |
| 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 | MS. TIARA RAE |
| Manufacturer Street | 101 ENTERPRISE, SUITE 100 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 8583204589 |
| Manufacturer G1 | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
| Manufacturer Street | 101 ENTERPRISE, SUITE 100 |
| Manufacturer City | ALISO VIEJO 92656 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92656 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM |
| Generic Name | GROWING ROD SYSTEM-MAGNETIC ACTUATION |
| Product Code | PNG |
| Date Received | 2019-09-03 |
| Model Number | RA002-5555SL |
| Lot Number | 1112158-010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE SPECIALIZED ORTHOPEDICS, INC |
| Manufacturer Address | 101 ENTERPRISE, SUITE 100 ALISO VIEJO CA 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-09-03 |