The California workers’ compensation community recently learned of questions raised about the authenticity of surgical screws used in spine implants at various hospitals in Southern California as a result of litigation brought by claimants who claim they received counterfeit hardware implants. The topic of questioning the manufacturing credentials of medical suppliers is now proving to potentially have significant benefits in claims administration strategies. It may be important to know more about what is at the forefront of implant technologies so that better treatment choices can be made. Unfortunately, the UR/IMR process typically answers the question “should someone have a surgery?” but typically omits answering the question “what brands of surgical implant devices are the best choice for the job?” To add to our knowledge about the surgical implant industry, here is some news about the latest surgical products recently approved by the FDA for spine surgeries.

The MEDICREA group, a company that specializes in the development of personalized implants produced for a patient’s specific need in the treatment of spinal pathologies, has announced the company has received 510(k) clearance from the U.S. Food and Drug Administration for UNiD, the world’s first patient-specific spinal osteosynthesis rod. The technology will be premiered at the 2014 North American Spine Society (NASS) Annual Meeting taking place on November 12-15 in San Francisco. The first U.S. patient underwent surgery to have personalized UNiD rods implanted earlier this month in New York.

UNiD is the first patient-specific device cleared to treat degenerative spine conditions including scoliosis and other type of deformities. According to the National Scoliosis Foundation, an estimated six million people in the U.S. have scoliosis. Each year scoliosis patients make more than 600,000 visits to private physician offices, and an estimated 38,000 patients undergo spinal fusion surgery. Adult spinal deformity surgery is likely to increase in frequency with as much as 32 percent of the adult population suffering from scoliosis and a prevalence of 60 percent among the elderly. Hospital costs of adult spinal deformity surgery can exceed $100,000 per patient. Revisions and reoperations place a large financial burden on the health care system – increasing the average cost of adult spinal deformity surgery by more than 70 percent.

UNiD patient-specific rods are universal implants available in two alloys (Titanium TA6V ELI/Cobalt Chromium) and two diameters (5.5 mm/6 mm), that match global standards. UNiD naturally fits into the PASS LP® thoraco-lumbar fixation system. The PASS LP® system is already used by numerous spine surgeons in 35 countries, and notably in the United States where this product accounts for the majority of MEDICREA USA Corporation’s sales. MEDICREA’s customized spine implant platform also includes the UNiD anterior lumbar interbody fusion (ALIF) spine cages created with a 3-D printer. With the support of specific software and advanced imaging, the UNiDTM ALIF customized cages made of Poly Ether Ketone Ketone (PEKK) exactly reproduce the anatomic details of a patient’s vertebral endplates. The world’s first spinal fusion surgery using the UNiD ALIF customized 3-D printed spine cages was performed on May 28, 2014 in France.

UNiDTM features a software tool to help surgeons preoperatively plan their surgery and order customized, industrially-produced rods to fit the specific spinal alignment needed for each individual patient. UNiDTM eliminates the need to manually contour a rod during surgery, providing surgeons with a precisely aligned rod prior to surgery and reducing the amount of time patients spend in the operating room, which directly impacts infection rate and quality of recovery.

The customized rod, according to the manufacturer, claims to offer numerous benefits to surgeons and patients undergoing spine surgery. The primary benefit is it allows surgeons to plan and then execute their operating strategy without compromises or approximation errors. Surgeons can improve their success rate in terms of global sagittal patient alignment, and reduce the risk of spinal implant failure.