N
Patient 1
NO PRODUCT HAS BEEN RETURNED FOR EVALUATION NOR WERE LAB CULTURE RESULTS PROVIDED TO CONFIRM THE ALLEGED EVENT. NO INDICATION OF PRODUCT MALFUNCTION WAS IDENTIFIED. BASED ON THE INFORMATION PROVIDED ROOT CAUSE COULD NOT BE IDENTIFIED.
MAUDE MDR 9908668
- MDR report key
- 9908668
- Report number
- 3006179046-2020-00161
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-06
- 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 | MC2-4570S | 9082102 | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. H; 2. O |
Event Narratives#
D
Patient 1
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER, THE PATIENT DEVELOPED AN INFECTION AND THE SURGEON DECIDED TO REMOVE THE ROD. THERE WAS NO ALLEGED DEVICE MALFUNCTION.