FDA EIR - Pantheon Spinal LLC - January 25, 2018

Pantheon Spinal LLC underwent an abbreviated FDA inspection from January 24-25, 2018, focusing on their Epiphany and Pontus Intervertebral Body Fusion Device (IBFD) Systems. The inspection, conducted under medical device regulations (21 CFR Part 820 Quality System Regulation), identified five significant observations documented on an FDA-483 form. Key violations included a lack of adequate design validation for their spinal implants, failing to assess the impact of multiple sterilization cycles on device functionality and material integrity. Additionally, the company initially lacked established procedures for managing post-market design changes, though this was rectified during the inspection. Their Corrective and Preventive Action (CAPA) system procedures were found deficient, not comprehensively addressing all quality data sources, investigation methods, action plan creation, or effectiveness validation. Furthermore, two out of three initiated corrective actions lacked proper closure documentation, including signatures, dates, and documented effectiveness. Finally, the firm's complaint handling system was inadequate, with a reported product issue (cracked implant) being incorrectly categorized as a nonconformance rather than a formal complaint, which was corrected during the inspection. Pantheon Spinal LLC committed to addressing the deficiencies, promising corrective actions and a written response within two weeks for the outstanding observations. The inspector emphasized the importance of full regulatory compliance and updated electronic Medical Device Reporting (eMDR) procedures.