The source of the alleged counterfeit screws that many say were implanted in patients across Southern California may have been found, but that still doesn’t put patient’s minds at ease.
The attorneys in the suit are naming William Crowder, a machinist who had worked on boat parts, car parts and plane parts- and now maybe spinal implant parts. He is claiming that a manager with Spinal Solutions’ (one of the facilities accused of using these counterfeit devices), Jeff Fields, presented him with “professional-looking” screws and asked if Crowder could make copies. The company would pay him almost half of what they would pay normally.
“He might want 50 of this size and 40 of these,” said Crowder, who has testified as making maybe 500 of these screws.
Richard Walker owns Ortho Sol which makes spinal fusion screws, and he discovered that some screws his company had repossessed from Spinal Solutions were not like the others. They repossessed screws from Spinal Solutions after they stopped paying their bills. He noticed that some of them were not made of his high quality materials and seemed to have fraudulent markings on them.
Crowder said he did not etch anything particular in the screws for Spinal Solutions, though the screws that came out of some patients had laser-etched marks. Perhaps to make them appear more legitimate?
There may be another Spinal Solutions employee who did the engraving. Ryan Zavilenski said that he did engraving for the company a few years ago but thought he was only engraving prototypes, and only worked on a handful of screws. But in pictures he posted online of the kinds of screws Spinal Solutions had available, manufacturers of those screws noticed that the logo on the version Zavilenski posted seemed vastly different than the logo on the screws the manufacturers made in their own facilities.
Walker said he actually toured Crowder’s shop a few years ago and said that the appearance of the shop alone would make him nervous if it was producing any medical equipment. Still, the FDA inspected his shop in 2012 and did not say it had any violations, nor did it recommend any changes.
Patients are understandably worried, fearing that their devices might start to break down and fail.
“I’m a walking time bomb,” said Susan Reynolds who had a procedure with Spinal Solutions screws and fears hers might be counterfeit.
Dr. Duncan McBride of UCLA said that surgical implant devices must be extremely precise in order to work.
“It’s like building a bridge in the back of someone’s spine. So if you have inferior material, it’s not going to work as well,” he explained.
The founder of Spinal Solutions, Roger Williams, lived a lavish lifestyle even as Spinal Solutions was going into bankruptcy. He is accused of taking doctors on private plane rides and treating them to other luxuries that may have convinced them to order Spinal Solutions screws instead of other suppliers. Before the overbilling jig was up in 2012, when California changed their laws, hospitals were able to bill almost $12,500 per screw.
A former employee for Spinal Solutions became a whistleblower and alerted the FDA, who is now in the middle of an investigation.