Becker's Spine Review

26 DEVICES & IMPLANTS NuVasive recalls Magec system for scoliosis, advises surgeons to perform clinical follow-ups By Alan Condon NuVasive issued an urgent field safety notice Feb. 13 recalling its Magec System Model X rods for patients with early onset scoliosis. e Magec system braces the spine during growth to minimize the progression of sco- liosis. e system is being investigated aer separation of an actuator end cap component was reported in 0.5 percent of Magec devices post-implantation. e separation of the end cap could lead to degenerated internal components and egress of titanium alloy wear debris, resulting in tissue discoloration. e company is advising spine surgeons to perform clinical follow-ups and discuss potential risks with patients who received the affected rods. NuVasive provided the following statement to Becker's: "First and foremost, NuVasive's priority is the safety of our patients and the ability to support our patients and surgeon partners. rough our post-market surveillance pro- cesses, we learned that in certain cases, Magec X rods experienced a post-implantation separation of an actuator end cap component. "Although there was a relatively low rate of endcap migration, on Feb. 13, 2020, the company chose to voluntarily recall its Magec X model rods as patient safety is our highest priority." n Aetna illegally refused to pay $75,200 for emergency spine procedure, practice alleges By Angie Stewart S an Jose Neurospine is battling Aet- na Health California in court, alleg- ing that the insurer illegally refused to pay for emergency medical services performed by spine surgeon Adebukola Onibokun, MD, the practice's owner. What you should know: 1. The case centers on a two-level lum- bar microdiscectomy that Dr. Onibokun performed in April 2017. San Jose Neu- rospine submitted two claims to Aetna for reimbursement — one for emergency medical services and one for nonemer- gency surgery. Aetna only provided pay- ment for the latter. 2. San Jose Neurospine filed a civil action against Aetna two months after appeal- ing Aetna's denial. The practice alleged that Aetna owed $75,200 for emergency medical services covered under the pa- tient's healthcare plan. 3. Aetna filed a motion for a summary judgment, claiming that San Jose Neuro- spine used incorrect codes and therefore wasn't entitled to payment for emergen- cy services. Aetna was granted the sum- mary judgment, meaning it showed that one or more elements of the plaintiff's case were missing or that it was entirely defensible, rendering a trial unnecessary. 4. San Jose Neurospine appealed the rul- ing. On Feb. 27, the California Court of Appeal in the Second District concluded "there are triable issues of fact whether SJN provided and billed for emergency services and was entitled to reimburse- ment from Aetna." The court reversed the summary judgment and remanded the case for further proceedings. n Bioventus taps former Stryker, Smith+Nephew executive as new CEO By Alan Condon The board of managers at Bioventus unanimously appointed Ken Reali to succeed Tony Bihl as CEO when he retired April 20. Mr. Reali has more than 28 years of experience in the medical device in- dustry, including executive roles at Stryker, Smith+Nephew and Baxano Surgical. Since 2015, he has operated as president and CEO of medical device company Clinical Innovations. Beginning his career at Biomet, Mr. Reali progressed to marketing director and vice president at Stryker, senior vice president and general manager at Smith+Nephew and president and CEO of spinal device company Baxano Surgical. He is on the boards of Ossio Integrative Orthopedics, AdvaMed and Ad- vaMed Accel and also serves as chairman of the ethics and compliance committee for AdvaMed. n

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