Fake Surgical Hardware in Hospitals

The University of Maryland’s Baltimore Washington Medical Center is sending letters to about 250 spinal fusion patients who received hardware from a defunct California company accused of selling fake parts. The Glen Burnie hospital is continuing to investigate whether any counterfeit parts were used in patients and sent the letters to “address any concerns.” Officials said they’ve found no evidence yet its patients were affected. A number of hospitals across the country, including Baltimore Washington Medical Center, have been sued by health insurers alleging the hospitals used the fake parts and overbilled for them. The suit also named one of the hospital’s spinal surgeons, Dr. Randy Davis. Local law firms are also investigating and reaching out to patients. The parts in question were distributed by a company called Spinal Solutions LLC, which was cited in 2012 by the U.S. Food and Drug Administration for quality control problems. The following year, the company recalled parts used in lower spine fusions, specifically saying that some had been distributed in Maryland. In announcing the recall, the FDA said inadequacies in the parts “might result in product performance failures that could cause patient harm due to implant breakage, movement, or inadequate sterilization.”

http://www.baltimoresun.com/health/maryland-health/bs-hs-fake-spinal-screws-20150716-story.html#page=1