Republic Spine found itself in hot water with the FDA for inadequate risk analysis and CAPA procedures as well as failure to develop written medical device procedures and design controls, following a March 2018 inspection of its Boca Raton, Florida, facility.

The devicemaker received a five-item Form 483 for deficiencies related to its Dark Star triple-lead pedicle spinal screw system.

A complaint handling procedure did not include requirements for transmitting medical device reports to the FDA and it lacked documentation and recordkeeping requirements. The firm also failed to fully implement design control procedures, the agency said, pointing to inadequate design planning, design verification, design validation, design reviews and design changes.