CerviCore was an experimental spinal implant manufactured by Stryker Corporation, through its Howmedica Osteonics division. The device was originally developed by a company called SpineCore, and Stryker purchased that company and the two devices the group was developing: CerviCore and a similar product, called FlexiCore, that was intended to be used in the lumbar spine.

CerviCore was designed as an alternative to traditional ACDF surgery: it was thought that instead of fusing the vertebrae above and below a damaged spinal disc, the CerviCore device could be inserted and that it would preserve range of motion, unlike fusion surgery.
In the hopes of getting full FDA approval, Stryker conducted a clinical trial of the device in about 240 people.

Manufacturing Errors

Stryker contracted with Hammill Manufacturing Company, a Toledo, Ohio medical device component manufacturer, to manufacture the upper and lower CerviCore baseplates that were used in the 240 CerviCore recipients.

CerviCore is a metal-on-metal articulating implant made of Chromium, Cobalt, and Molybdenum (CoCrMo) with a sprayed Titanium (ti) coating.

CerviCore’s design called for the two articulating surfaces—that is, the surfaces that would rub against each other to make the joint—to be polished to a mirror-like finish. It also called for the saddle shape to be manufactured to extremely precise tolerances.

These precision design requirements were essential to CerviCore’s safety because they directly lead to whether the device sheds metal debris as it articulates (moves) against itself.

Either Hammill lacked the capability of manufacturing the units to specifications, or it was too expensive to do so. But, instead of stopping, Hammill made the units out-of-spec. Hammill quietly wrote down the out-of-spec measurements, boxed up the devices, and shipped them to Stryker who shipped them to implanting surgeons around the country.

Hammill is responsible for these errors, but the responsibility doesn’t stop with Hammill for two reasons: (1) Stryker also knew the units were being made out-of-spec and shipped them to surgeons anyways, and (2) Stryker is the “Manufacturer of Record,” meaning it is ultimately responsible for its unsafe medical devices.

Metallosis

CerviCore is made up of two pieces: an upper baseplate and a lower baseplate. By design, they form an articulating joint, meaning they move against each other to simulate a natural body joint.
Hammill shipped units that were made out of specifications in that they were not made to the required tight tolerances and they were not properly polished to a mirror-like finish.

When manufacturing mistakes are made in creating metal-on-metal articulating devices, those devices can release exponentially more metal ions and metal debris than is safe. Such is the case with CerviCore. Plus, there is a complicating factor: instead of releasing these metal ions into a hip or knee area, they are released into the spinal column, a much more sensitive and delicate area.

“Metallosis,” which is a buildup of metal debris from a medical implant, can cause all sorts of sickness and disorders. In the bloodstream, it triggers autoimmune reactions. In situ, it causes pseudotumors as the body works to encapsulate the foreign matter.

The Cover Up

Stryker had promised to keep the CerviCore study subjects safe and to keep them informed of any new information it learned about the product now in their necks.
But, the company knew of the manufacturing defects and said nothing.

As the CerviCore clinical trial progressed, adverse event reports surfaced that showed patients having metallosis reactions, but the company “adjudicated” each one as an isolated event not related to the device.

The FDA repeatedly raised concerns about the safety of metal-on-metal devices, but Stryker never passed these warnings on to the surgeons who were providing care to the 240 CerviCore recipients.

And, when Stryker gave up on trying to get CerviCore approved and applied for permission to end the clinical trial, the FDA allowed that only if Stryker warned doctors and patients about the potential metallosis danger, but Stryker never did that.

Once the CerviCore product no longer had the potential to make Stryker money, the company engaged in a full-scale cover-up. It aggressively told the implanting surgeons that their patients were imagining symptoms or that their symptoms were not related to the CerviCore device. All the while, Stryker knew the product was actually made defectively. The company even told the FDA, surgeons, and patients that it knew of no risk associated with the device even though it knew of the manufacturing errors and the sickness they are causing. Still to this day, Stryker has not come clean to the 240 people involved in the CerviCore clinical trial.

FDA Rejection

To this day, Stryker has never disclosed the dangers associated with CerviCore or the fact that it knows they were mis-made. Not to the FDA, not to the implanting surgeons, and not to the 240 people who volunteered to receive the experimental device. The majority of those volunteers still have the faulty device in their cervical spines.

Unrelated to these failures, FDA rejected several of Stryker’s attempts to get full commercial Pre-Market Approval (PMA) and the agency finally deemed both the CerviCore device and the FlexiCore device not approvable. Since then, Stryker has abandoned the devices—and the people who received them.

Litigation

In 2014, attorney Jim O’Brien began investigating Stryker Corporation and its CerviCore device as well as the related FlexiCore device. This led to uncovering the manufacturing errors and the cover-up.

Through the last few years, O’Brien has brought suit on behalf of nearly two dozen CerviCore and FlexiCore recipients. These people—who volunteered in the interest of science and on the understanding they would be taken care of if something went wrong—want honest answers and responsive medical care more than anything else.

Did Stryker Tell Hammill to Release Faulty Parts?

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There is not much legitimate dispute that the CerviCore devices used by Stryker in the CerviCore clinical trial were mismade. Stryker relied on its subcontractor, Hammill Manufacturing, to make the…