Issue link: https://beckershealthcare.uberflip.com/i/1220364
12 ORTHOPEDICS 5 spine, neurosurgery devices recalled in 2019 By Alan Condon Here are five spine and neurosurgical devices recalled by the FDA in 2019: 1. Johnson & Johnson's DePuy Synthes voluntarily recalled its USS II Polyaxial 3D heads, according to an urgent field safety notice issued out of Switzerland in November. e devices are part of the USS II Polyaxial System, a posterior pedicle screw fix- ation system designed to provide spine stabilization in skeletally mature patients, and not available in the U.S. 2. Zimmer Biomet recalled the ROSA Brain 3.0 Robotic Surgery System in November due to a soware issue that can drive the robotic arm to an incorrect position. Zimmer Biomet received five complaints related to the issue, including one patient injury. No deaths related to this issue were reported. 3. Alpha Omega Engineering's Neuro Omega system, used to assist neurosurgeons in identifying brain structures during neu- rosurgery, was recalled in May due to a design flaw that may fuse two separate electrode stimulation channels into one. e flaw, causing unplanned electrical stimulation, could cause significant harm to a patient's brain tissue. No patient injuries or deaths were reported. 4. In April, Brainlab recalled its Spine & Trauma 3D Naviga- tion Soware due to the potential for incorrect information to display during surgery, which may prevent the surgeon from accurately navigating tools inside the patient. e flaw could result in a second surgical procedure, life-threatening patient injuries or death. 5. Medtronic recalled the Synergy Cranial Soware and Stealth- Station S7 Cranial Soware used with the StealthStation Surgical Navigation System in January. e recall was due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm. e so- ware defect could affect the neurosurgeon and have them insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels. n American College of Sports Medicine taps new CEO By Eric Oliver K ristin Belleson will serve as the new CEO of the American College of Sports Medicine, effective Feb. 3. What you should know: 1. Ms. Belleson was the top choice of the organi- zation's search committee. 2. She comes to ACSM after a tenure as the interim COO at the American Osteopathic As- sociation. She has also worked with the American Dental Association, the Society of Gynecologic Oncology and Foundation for Women's Cancer, and the Healthcare Financial Management As- sociation. 3. Ms. Belleson has more than 20 years of experi- ence in association and nonprofit management. Ms. Belleson said, "I have a deep love and pas- sion for athletics and sports, which has helped me to understand the importance of not only health and fitness but also the importance of teams and collaboration." n Indiana orthopedics group to open $10M MOB, quadrupling in size: 4 notes By Laura Dyrda M unster, Ind.-based North Point Orthopaedics aims to quadruple its space with a new medical office building, according to The Times. Four things to know: 1. Five physician partners broke ground on their new 25,000-square-foot facility, which is expected to cost $10 million. 2. The practice's initial location opened 12 years ago as a solo practice, and has grown to now include seven physi- cians. Gregory McCormis, MD, who founded the practice, told The Times that the group will soon add two more physicians as well. 3. North Point has grown to 35 employees over the past 18 months and needed more space. The practice facility will also include physical therapy, urgent care, X-ray and ultrasound. 4. The physicians expect to move into the new location this October. n