N
Patient 1
NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. NO LAB CULTURE RESULTS WERE PROVIDED TO CONFIRM THE REPORTED EVENT. NO ROOT CAUSE CAN BE CONFIRMED AT THIS TIME.
MAUDE MDR 9908859
- MDR report key
- 9908859
- Report number
- 3006179046-2020-00163
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-01-08
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. TIARA RAE
- Address
- 101 ENTERPRISE SUITE 100 ALISO VIEJO CA 92656 US
- Phone
- 619-619-6197
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | GROWING ROD SYSTEM-MAGNETIC ACTUATION | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. | PGN | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. H |
Event Narratives#
D
Patient 1
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018. AS PER REPORTER, THE PATIENT DEVELOPED AN INFECTION. IT IS UNKNOWN IF THE INFECTION WAS RELATED TO THE DEVICE.