FDA WARNING_LETTER - Vertebral Technologies, Inc. - February 02, 2015

This FDA Warning Letter, dated February 13, 2015, was issued to Vertebral Technologies, Inc. following an inspection from January 28 to February 2, 2015. The inspection revealed that the firm, which manufactures intervertebral body fusion devices, including the InterFuse L, S, and T, had misbranded its InterFuse S device.

The misbranding stemmed from significant deviations in Medical Device Reporting (MDR) requirements under 21 U.S.C. § 352(t)(2) and 21 CFR Part 803. Specifically, the firm failed to report device malfunctions within 30 calendar days, as required by 21 CFR 803.50(a)(2). Examples cited include complaints CIR numbers 2011-001, 2011-002, 2011-003, 2011-007, and 2009-006, where the device malfunctioned post-implantation, and no justification was provided that recurrence would not cause serious injury or death.

Furthermore, the firm failed to adequately develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17(a). Their procedure, "SOP 024, Complaint Handling," Revision: D, lacked timely