Over the summer, the Center for Investigative Reporting (CIR) broke the story of surgeons who used counterfeit screws and rods in spine surgery, causing crippling outcomes and mounting lawsuits. Now, the CIR has published the back story in a chilling tale of greed and regulatory sloth.
Ortho Sol makes precision screws for spinal fusion surgery. In 2009, it repossessed some of its screws after Spinal Solutions LLC failed to pay for them. An Ortho Sol executive noticed that some of the screws it got back were counterfeit, that Spinal Solutions had replaced high-quality, safe equipment, with cheap knockoffs that had been implanted in the necks and backs of who knows how many people in the U.S.
Two years later, a whistle-blower from Spinal Solutions tipped off the FDA about the counterfeiting, and even then, the feds didn’t shut down the company. “By the time Spinal Solutions went broke in 2013,” CIR reports, “the company had sold millions of dollars in implants to a nationwide network of surgeons.”
Some surgical patients have suffered debilitating pain and infections from the counterfeit screws, but others whose doctors were among the recipients of Spinal Solutions shipments that mixed legitimate and counterfeit screws are left wondering about their future.
“What do they do if they find out there are these bogus parts that can come unscrewed?” Susan Reynolds told CIR. Her doctor used Spinal Solutions screws in her surgery in 2009. “I’m a walking time bomb.”
Many doctors received lucrative consulting deals from Spinal Solutions, and in return, used the company’s implants for their surgeries at hospitals in California, Nevada, Texas, Wisconsin and Maryland. CIR has no evidence they knew the screws were counterfeit, but some doctors have been accused of with taking kickbacks for using them.