FDA WARNING_LETTER - Pioneer Surgical Technology - April 22, 2010

On August 3, 2010, the FDA issued a Warning Letter to Pioneer Surgical Technology, Inc. following an inspection from April 19-22, 2010, at their Marquette, MI facility. The inspection assessed compliance with federal regulations for the clinical study "A Prospective, Multi-Center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NuBaC? Disc Arthroplasty" (IDE (b)(4)).

The FDA identified several violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects). Key violations included:

1. **Promotion of an investigational device as safe and effective (21 CFR 812.7(d)):** A video on a clinical investigator's website promoted NuBac as safe and effective, made comparative claims, and included a testimonial without describing risks, potentially unduly influencing subjects. 2. **Failure to include all elements of informed consent (21 CFR 50.25(a) and (b)):** The November 11, 2008, informed consent form lacked required elements such as identification of experimental procedures, foreseeable risks, contact information for questions, and statements regarding unforeseeable risks or new findings. 3. **Failure to ensure adequate monitoring and supply investigational plans (21 CFR 812.40 and