February 21, 2018

Houston, Texas and National NuVasive Injury Attorneys

NuVasive MAGEC System

On September 8, 2016, NuVasive Specialized Orthopedics, Inc received 510(k) clearance to market and sell the NuVasive MAGEC System. The NuVasive MAGEC System appears to be an evolution of the of a similar device created by Ellipse Technologies, Inc., which NuVasive purchased in 2016. According to the 510(k) clearance letter from the FDA, the NuVasive MAGEC System is indicated for use in for skeletally immature patients less than 10 years of age with severe progressive spinal deformities associated with or at risk for Thoracic Insufficiency Syndrome (TIS). TIS is the inability of the thorax to support normal respiration. The majority of the NuVasive MAGEC System appear to be used in children with scoliosis, which is condition of the spine wherein it curves to the left or the right. According to the National Scoliosis Foundation, scoliosis affects 2-3% of the population, or approximately 7 million people.[1] Only a small subset of this 2-3% would require surgical intervention with devices such as the NuVasive MAGEC System..

Studies Raise Concerns About MAGEC growing rods

A study published in the January 2018[2] issue of Spine analyzed 34 explanted MAGEC growing rods from seven United Kingdom spinal centers. This study found titanium wear debris in all 34 explants, 31 explants showed measurable wear of the extending bar, substantial damages was seen in the radial bearing in 25 rods, and O-ring failure was seen in 18 cases. In 15 rods the drive pin was fractured.

A case series published in a 2016 issue of the Bone and Joint Journal[3] found that metallosis was found during revision surgeries in 4 of 5 patients implanted with magnetic controlled growing rods and “highlights concerns with tissue metallosis in magnetic controlled growing rods.” The FDA has published information on metallosis in the context of other orthopedic devices, specifically metal on metal hip implants.[4] The FDA states that metal particles from a metal-on-metal implants may cause a reaction in the area around the implant, leading to deterioration of the tissue around the implant, loosening of the implant and failure of the device. Metal ions from a metal-on-metal implants can enter the bloodstream. There are case reports in which patients with metal-on-metal hip implants may have developed an adverse reaction to these metal ions and experienced medical problems that could have been related to their implants. These problems include general hypersensitivity reaction (skin rash), cardiomyopathy, neurological changes including sensory changes (auditory, or visual impairments), psychological status change (including depression or cognitive impairment), renal function impairment and thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold).

An April 2016 study in Spine followed 8 patients implanted magnetic controlled growing rods  over 4 years and concluded that “[m]edium-term results of MCGR are not as promising as previously reported early results. Hence, MCGRs should be used with caution.”[5]

 

NuVasive MAGEC System Investigation

Vickery & Shepherd is investigating whether there are any viable claims that can be made against NuVasive regarding their MAGEC System, including whether or not the NuVasive MAGEC System in defectively designed or did NuVasive fail to warn doctors about risks related to the MAGEC System that were known (or should have been known) by the company.

 

VICKERY & SHEPHERD-NATIONAL AND TEXAS MEDICAL DEVICE ATTORNEYS

For two decades, the attorneys at Vickery & Shepherd have represented individuals and their families who have been injured by pharmaceuticals and medical devices. If you or your loved one has suffered an injury that you believe is due to NuVasive MAGEC System, please contact us at 713-526-1100. We are investigating these potential claims.

 

Sources:

[1] http://www.scoliosis.org/info.php

[2] https://www.ncbi.nlm.nih.gov/pubmed/28459777

[3] https://www.ncbi.nlm.nih.gov/pubmed/27909129

[4]https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241766.htm

[5] https://www.ncbi.nlm.nih.gov/pubmed/26844638