MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-13 for MAGEC SPINAL BRACING AND DISTRACTION SYSTEM RA002-5555SL manufactured by Nuvasive Specialized Orthopedics, Inc..
| Report Number | 3006179046-2020-00138 |
| MDR Report Key | 9830061 |
| Report Source | OTHER |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | ALISA VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 6197314188 |
| Manufacturer G1 | NUVASIVE SPECIALIZED ORTHOPEDICS |
| Manufacturer City | CA 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 | PGN |
| Date Received | 2020-03-13 |
| Model Number | RA002-5555SL |
| Lot Number | A140401-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-13 |