FDA WARNING_LETTER - VertiFlex, Inc. - February 11, 2010

The FDA issued a Warning Letter to VertiFlex, Inc. following an inspection from February 2-11, 2010, identifying significant violations related to their Dynabolt? Dynamic Stabilization System.

The Dynabolt? device was cleared under K073143 for specific indications as a pedicle screw fixation system. However, VertiFlex is marketing and promoting the Dynabolt? for uncleared indications, including degenerative disc disease, severe spondylolisthesis (Grades 3 and 4), trauma, spinal stenosis, deformities/curvatures, and tumors. Additionally, the Dynabolt? is being promoted for use with Silverbolt and/or Mainframe systems (K073245) components, which was not part of its clearance and requires a new 510(k) submission. These actions render the device adulterated under Section 501(f)(1)(B) and misbranded under Section 502(o) of the Federal Food, Drug, and Cosmetic Act. The FDA demands immediate cessation of such promotional activities.

Furthermore, the inspection revealed misbranding of the Dynabolt? and Silverbolt systems under Section 502(t)(2) due to failures in Medical Device Reporting (MDR) as required by 21 CFR Part 803. Specifically, VertiFlex failed to report adverse events within 30 calendar days,