Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.
Product is impacted by a thread profile defect due to a manufacturing issue.
International distribution in the countries of France, Switzerland and Jordan. No US distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1797-2021