Nov 28, 2018

Written by Shayna Korol | November 27, 2018 | Print  | Email The now-defunct Ranier Technology sold spinal implants that allegedly moved and eroded in patients, according to The Guardian . Here are six things to know: 1. Ranier Technology received CE safety marks for its Cadisc-L and Cadisc-C implants, which were certified by the British Standards Institution in 2010 and 2011, respectively. The implants were then marketed to hospitals across Europe for degenerative disc disease treatment. 2. Approximately half of the patients who received the Cadisc-L implants have undergone further surgery after the discs disintegrated or moved in their backs, according to the Implant Files investigation, which was coordinated by the International Consortium of Investigative Journalists and involved The Guardian and BBC's Panorama. 3. A customized Cadisc-L disc was implanted in baboons and detailed in a Orthopaedic Proceedings study. According to the Implant Files investigation, the discs were misplaced in the baboon trials. 4. The results of human trials have not been published but ran for six months before Ranier submitted a CE mark application. 5. Ranier chose to seek approval in Europe before the U.S., allegedly to use the CE mark approval to get FDA clearance. The FDA asked for more data to support the approval application. 6. The company dissolved in 2018. In a statement to The Guardian, Ranier founder Geoffrey Adams said the Cadisc-L devices used in humans were not the same ones used in the baboon trials. He claimed clinical tests in patients had gone well, and the company, "decided unilaterally, and as a precaution, to formally withdraw Cadisc-L from the market, which it did on March 31, 2014," after four patients underwent revision surgery. More articles on devices: