InjuryPGN
MAGEC GENERATION 2 SPINAL BRACING AND DISTRACTION SYSTEM
Received Dec 3, 2024 · Event occurred Oct 31, 2024
Report 3006179046-2024-00186 · MDR key 20835908
Device
Generic name
Growing Rod System - Magnetic Actuation
Manufacturer
Nuvasive Specialized Orthopedics, IncorporatedModel number
MS2-6090SCatalog number
NA
Lot number
9121016
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
7 YR · Male
- Drug Resistant Bacterial Infection
- Drug Resistant Bacterial Infection
Narrative
Description of Event or Problem
A REVISION PROCEDURE WAS PERFORMED AFTER SEVERAL INCISION AND DRAINAGE (I&D) PROCEDURES TO ADDRESS AN ABSCESS WITH WOUND CLOSURE. THIS WAS REQUIRED DUE TO AN INFECTION FOLLOWING DEVICE IMPLANTATION.
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.