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 |