InjuryPGN
MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM
Received May 19, 2025 · Event occurred May 1, 2025
Report 3006179046-2025-00113 · MDR key 22047739
Device
Generic name
Growing Rod System- Magnetic Actuation
Manufacturer
Nuvasive Specialized Orthopedics, Inc.Model number
RA002-5555SLRCatalog number
PA0296
Lot number
A171227-01
Product problems
- Fracture
- Fracture
Patient
NA · Male
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
INFORMATION WAS RECEIVED INDICATING THAT A REVISION PROCEDURE WAS PERFORMED AT THE T3 LEVEL DUE TO FRACTURED BILATERAL RODS. DURING THE REMOVAL PROCEDURE, IT WAS OBSERVED THAT BOTH RODS EXHIBITED ACTUATOR FAILURE AND WERE FREELY MOBILE.