FDAnews Device Daily Bulletin

No Quality System in Place at Spinal USA, Warning Letter Says

Jan. 4, 2008

Medical devicemaker Spinal USA has “no quality system in place to control and monitor the development, repackaging and labeling of finished medical devices,” a recent FDA warning letter said.

The company manufactures the Slimplicity Anterior Cervical Plate System, the Spinal USA Cement Restrictor and the Spinal USA Vertebral Body Replacement System.

The devices are adulterated, the letter said, citing several discrepancies between documents and procedures on file at the firm and those on file with the company’s contract manufacturer.

For example, the specifications and diagrams on file for certain devices did not match the specifications and diagrams of the contract manufacturer for the same devices.

The warning letter can be seen at www.fda.gov/foi/warning_letters/s6602c.pdf.