Case Study: A Fracture Warning

In 2002, a device company that makes a “bone-void filler” received 510(k) clearance to market its product for use in filling bony “voids or defects” except those related to “vertebral compression fractures,” as the label on the product indicated. During a routine inspection of the company, FDA discovered training materials such as presentations, CDs, and informational literature for surgeons that focused on using the device to treat vertebral compression fractures.