Spinal Fusion Patients May Have Received Fake Medical Screws, Lawsuits Allege

Lawsuits suggest that hundreds of individuals may have undergone spinal fusion surgery in recent years where fraudulent or counterfeit parts could have been implanted in their bodies, potentially putting them at risk for serious complications caused by the sub-standard parts.

The Baltimore Sun reports that the University of Maryland’s Baltimore Washington Medical Center is sending letters to an estimated 250 spinal fusion patients, addressing concerns regarding potentially counterfeit parts that may have been used during certain procedures.

The hospital is one of about 17 nationwide affected by a recall of parts provided by the now-out-of-business Spinal Solutions, LLC., which may have intermingled with counterfeit parts that were never approved by the FDA as safe and effective, in what many describe as a massive health care scam.

At issue are parts manufactured by Spinal Solutions LLC, which were recalled in 2013 following an FDA warning letter that identified quality control problems. The FDA claimed that inadequate lower spine fusion parts could break, might be inadequately sterilized or move out of position.

Spinal Solutions went out of business after the recall. However, according to a recent lawsuit filed against the California-based company, many hospitals not only received parts that were of low quality, but that they may have actually involved counterfeit parts intentionally interspersed with real parts as part of a fraud scheme.

Among allegations raised in the claims are that a surgeon at University of Maryland’s Baltimore Washington Medical Center entered into an agreement with the company to use the products during surgery and was paid $458,962 in return for implanting them in patients. A number of other surgeons nationwide face similar allegations as part of a lawsuit filed by insurers.

The lawsuit was actually filed in February, but remained sealed for months. The complaint covers a period spanning from 2007 to 2012.

According to allegations raised in the complaint, the parts were co-mingled with real ones and would be extremely hard to detect. However, if they fail, patients could experience spinal fusion surgery complications that could result in injuries and require additional surgeries.

That lawsuit isn’t the first of its kind against Spinal Solutions or those associated with it. Suspicions were originally raised in 2009, when some parts suppliers, who had their parts distributed through Spinal Solutions, suspected the company was making knock-off versions of its parts, and pocketing the proceeds.

Those allegations were highlighted in a lawsuit filed in California in 2012, in which suppliers said they found clones of their products made with substandard materials, with fake laser-etching, counterfeit logos and poor screw alignments that could affect patients in numerous ways.

The issue has raised questions about how hospitals are informed about potentially defective or counterfeit parts, as it appears the fake Spinal Solutions hardware was used for some time. It also raises questions about the spread of counterfeit medical parts in the supply chain, with the World Health Organization indicating that as much as 8% of medical devices may be fake, though most of those devices are likely used in low-risk procedures.