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.

For example, the design plan did not include a development schedule with all tasks, review stages and milestones clearly defined, nor did it identify all contributors to the development process and their responsibilities. The design history file also lacked evidence that the design verification was performed on the physical characteristic input requirements listed on the design input/output matrix, the FDA said.

Moreover, there was no approved protocol in the design history file to perform design validation to include an explanation for a simulated environment. The investigator found two different design development validation forms with different dates and no explanation for the discrepancy.

The FDA said the firm’s risk analysis was inadequate in that it failed to justify how it arrived at certain ranges for the spinal system, and some of the risk mitigation methods did not describe changes implemented to mitigate risk. The firm was also not using feedback such as complaints to review its failure mode effects analysis (FMEA) to “determine if new hazards have been identified and may require mitigation.”

For example, one complaint identified a new at-fault hazard of device fractures due to improper continuous loading/unloading, but the hazard was not added to the FMEA document.