FDA WARNING_LETTER - Jenis, Louis G., M.D. - December 07, 2011

The FDA issued a Warning Letter to Dr. Louis G. Jenis following an inspection from November 15 to December 7, 2011, concerning his participation in a clinical study of the Discover Artificial Cervical Disc (IDE G060020). The inspection revealed serious violations of 21 CFR Part 812, Investigational Device Exemptions.

Key violations include: 1. **Failure to conduct the investigation according to the signed agreement and investigational plan (21 CFR 812.100 and 812.110(b))**: Dr. Jenis implanted the control article on the incorrect cervical spine level for Subject (b)(6) and subsequently performed a second, unauthorized two-level fusion surgery on the same subject, placing the subject at increased risk. 2. **Failure to maintain accurate, complete, and current records of each subject’s case history (21 CFR 812.140(a)(3))**: Numerous inconsistencies were found, including unrecorded adverse events (AEs) and serious adverse events (SAEs) for multiple subjects (e.g., pain, numbness, device migration, cardiac arrest), incorrect onset dates for AEs, and incorrect subject numbers in reports. 3. **Failure to submit progress reports to the sponsor and IRB at regular intervals (21 CFR 812.100, 812