Spinal Concepts gets FDA warning on BacFix problem
This article was originally published in Clinica
Failure to keep records about an instrument failure and document how it was fixed has earned Spinal Concepts (Austin, Texas), an FDA warning letter. The company makes the BacFix Thoracolumbar System, the Harmonym PLIF Instrument Set and the Cadence Vue vertebral body replacement device.
During a series of inspections in February, investigators uncovered numerous complaints about a breakage problem involving an instrument used to implant the BacFix. It turned out that the tip on the coldwelder instrument tended to break, the agency said, but there was incomplete information about the problem in the complaint files. Moreover, the firm did not document its many attempts to remedy the apparent design flaw, the FDA said.
The company also failed to establish and maintain procedures for rework and to document rework and re-evaluation activities, failed to document that it investigated whether coldwelder parts were being incorrectly heat treated, and how it dealt with the contract manufacturer who did it, the FDA said. The warning letter also cites the company for failing to follow design controls for Cadence Vue.
The company responded to the agency's letters in February and early June, and continues to review them.