InjuryPGN
MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM
Received Apr 21, 2025 · Event occurred Sep 4, 2024
Report 3006179046-2025-00108 · MDR key 21875661
Device
Generic name
Growing Rod System- Magnetic Actuation
Manufacturer
Nuvasive Specialized Orthopedics, Inc.Model number
MC2-4590SCatalog number
NA
Lot number
2131604
Product problems
- Failure to Advance
- Failure to Advance
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
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD FAILING TO DISTRACT. THE REVISION SURGERY WAS COMPLETED WITH NO ISSUE OR ADVERSE CONSEQUENCES TO THE PATIENT.