The FDA in October 2012 inspected NuVasive’s San Diego, Calif., manufacturing facility, finding only the single violation regarding marketing language for the company’s Affix Spinous Process Plate System.
NuVasive had marketed the Affix devices "as an adjunct to interbody fusion (XLIF®, ALIF, PLIF, and TLIF.)," according to the FDA inspection report.
"Although your firm has multiple 510(k)s cleared for this device, none of them include the use of the Affix plate with only an intervertebral body fusion device," the inspectors said. "This constitutes a new intended use and a new 510(k) is required."
NuVasive updated shareholders on the warning letter, noting that the violations relate only to language about the Affix device and that there were no issues with manufacturing at the facility.
"The company takes this matter seriously and has already begun to respond to the FDA’s requests," NuVasive said in a regulatory filing. "The company is giving the matter the highest priority in order to fully address the FDA’s concerns to our mutual satisfaction. As this is an administrative process to address the warning letter, the Company believes the FDA’s concerns can be resolved without an impact on the company’s financial results or operations."
NuVasive doesn’t expect that the issue will affect distribution of devices from the facility, the company added.