Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Intraoperative pedicle fractures requiring further points of fixation. Ann Thorac Surg. Don't jump in get legal help. The site is secure. pedicle screw misplacement malpractice. Spine 18:11601172, 1993. The medicolegal landscape of spine surgery: how do surgeons fare? The accuracy of pedicle screw placement using intraoperative image guidance systems. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. were excluded from analysis. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. The patient had to undergo a subsequent surgery to remove the pedicles. Your current browser may not support copying via this button. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. Both issues represent the most frequent and highest payouts in spine malpractice claims.10,14,22 While several studies have explored many of the factors related to malpractice claims in spine surgery, the medicolegal impact of misplaced pedicle and/or lateral mass screws has not been directly reported in the literature. Legal liability in iatrogenic orbital injury. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. Pedicle screw fixation is commonly used in spinal instrumentation surgeries to connect rods to vertebrae in order to correct spine alignment, stabilize vertebrae, and reach an arthrodesis. Nottmeier EW, Seemer W, Young PM. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. All case demographics are summarized in Table 1. Objective: General complications were considered those developing during and after surgery that were not directly related to instrumentation. A.J. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. 2014;174(11):18671868. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. Spine 15:1114, 1990. Svider PF, Kovalerchik O, Mauro AC, et al. Analysis and interpretation of data: Sankey, TT Than. 2018;83(5):9971006. Level of evidence: Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. Medical malpractice litigation has made a significant impact on spine surgery, with many spine surgeons avoiding complex cases or practicing other defensive medicine tactics in an effort to avoid being sued.5 Moreover, the majority of neurosurgeons spend more than 10% of their annual revenue on malpractice insurance,1,14 and the excessive financial risk of litigation is even leading some insurers to no longer offer coverage to spine surgeons.19 A 2011 study in the New England Journal of Medicine found that 19.1% of neurosurgeons are named as a defendant in a malpractice suit each year (highest of any specialty).12 Moreover, 88% of physicians in high-risk specialties, like neurosurgery, are involved in a lawsuit by age 45, increasing to a concerning 99% by 65 years of age.12 Such litigation places a substantial financial, temporal, and emotional burden on physicians in high-risk specialties, with studies showing that up to 72% of neurosurgeons1 admitted that their fear of litigation significantly influenced their practice,25 with many avoiding high-risk patients altogether.1 Similarly, Nahed et al. 144 Quraishi NA, Hammett TC, Todd DB, et al. Instead, the defense offered up an alternative explanation for Nyquists foot drop. Plaintiff-awarded cases by US region (left). Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Under the high-low agreement, Drs. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Problems of balance were coronal (scoliosis greater than 5 or trunk shift greater than 5 mm) as seen on the AP radiograph taken with the patient standing or sagittal (failure to obtain or maintain lumbar lordosis). Rather, the defense demonstrated that although the misplaced screw had in fact irritated the L4 nerve root for the six days before it was removed, the related symptoms resolved with the screws removal. 39. (A) Anteroposterior and (B) lateral radiographs taken 1 year after surgery show upper screw breakage in the application of a short Cotrel-Dubousset construct in a T12 burst fracture. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). Mason A, Paulsen R, Babuska JM, et al. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. Judgment information associated with a defendant (surgeon) versus plaintiff (patient) ruling, trial versus settlement versus arbitration decision, award amount, and time to decision or case closure from index surgery was also recorded. 20th Annual Spine, Orthopedic & Pain Management-Driven ASC Conference, 8th Annual Health IT + Digital Health + RCM Conference, 29th Annual Meeting - The Business & Operations of ASCs, The issues spine surgeons are advocating for outside of the operating room, Centinel Spine is now covered by all major payers, What's next for SI joint fusion? ObjectThe goal of this study was to determine the incidence of screw misplacement and complications in a group of 102 patients who underwent transpedicle screw fixation in the lumbosacral spine with conventional open technique and intraoperative. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. doi: 10.1097/BRS.0b013e31822a2e0a. However, the misplacement of pedicle screws can lead to disastrous complications. 2018;27(9):23392347. All the incidental dural tears were repaired immediately and produced no clinical sequelae. 2012;37(1):6776. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. Careers. Eur Spine J. 2016;124(5):15241530. J Am Coll Surg. This decision must be made on a case-by-case basis at the surgeons and patients discretion after a thorough discussion of the associated risks and benefits of revision surgery. Conception and design: Sankey, KD Than. This patient recovered completely in 6 weeks. Before 2013;34(6):699705. 2021 Jul 1;41(Suppl 1):S80-S86. Epub 2022 Oct 29. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Copyright 2023 Becker's Healthcare. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. 2016;25(3):716723. Background The objective of this cadaveric study was to analyze the effects of iatrogenic pedicle perforations from screw misplacement on the mean pullout strength of lower thoracic and lumbar pedicle screws. 16. And while the jury debated for about two hours, at the end of its deliberation it sided with the defendants and entered a not guilty verdict. Better strategies need to be devised for evaluation of screw placement, including establishment of a national database of deformity surgery, use of intra-operative image guidance, and reevaluation of postoperative low-dose CT imaging. The average age of the patients was 47 years and the average followup was 35 months. 2012;41(2):6973. 15. The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). Spine (Phila Pa 1976). However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. J Bone Joint Surg 54A:11951204, 1972. Despite these failures, solid spinal arthrodesis was obtained in all patients. Median screw misplacement rate was 10% in group A and 13% in group B. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Patient safety: disclosure of medical errors and risk mitigation. Under this theory of liability, the plaintiff needed to not only establish that she had experienced foot drop, a fact that no one was disputing, but that it was caused by the defendants negligence. JAMA Intern Med. 23. Routine CT scans were taken in all patients. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. Spine 17:834837, 1992. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. (A) Anteroposterior and (B) lateral radiographs show coronal imbalance that developed 4 years after surgery in a 57-year-old woman with L3L4 float fusion. 21. Acta Neurochir (Wien). Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Can Postoperative Radiographs Accurately Identify Screw Misplacements? 27,30 Infected pseudarthrosis developed in one patient (0.9%) with an L4S1 arthrodesis, and the instrumentation was removed 18 months later resulting in a flat back syndrome. Operative information including fusion level, number of levels fused, level of misplaced screw(s), single versus multiple misplaced screw(s), presence of known CSF leakage, and primary injury due to screw misplacement was also collected. Epstein NE. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. Spine (Phila Pa 1976). The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. ABSTRACT: Pedicle screw loosening has been implicated in recurrent back pain after lumbar spinal fusion, but the degree of loosening has not been systematically quantied in patients. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. Studdert DM, Mello MM, Sage WM, et al. In the current study, no incidence of bent and broken screws or tulip screw plug dislodgement necessitated additional treatment, and all the patients achieved solid fusion despite the failure of instrumentation. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. Bydon M, Xu R, Amin AG, et al. Smith TR, Hulou MM, Yan SC, et al. 1). 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Friedlander and Bradley will pay half of the $2.25 million. 3. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. doi: 10.1097/BPO.0000000000001828. Continued clinical experience with various pedicle screw implant systems has led to ongoing improvements in system design to minimize implant failure rates and to improve ease of system application. 5. 2. Thus, in the current study we aimed to describe this impact in the US, as well as to suggest a potential method for mitigating the problem. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Nevertheless, research has shown that screws are misplaced in approximately 14%55% of cases using the standard techniques (freehand and 2D fluoroscopic guidance) employed by most spine surgeons,21,33 resulting in injury in approximately 1%8% of cases.21 In addition to the avoidable procedural risk to the patient, each misplaced screw carries the threat of future litigation, as reported above. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. Department of Neurosurgery, Spine Division, Duke University Medical Center, Durham, North Carolina; and, Malpractice liability and defensive medicine: a national survey of neurosurgeons, Defensive medicine among high-risk specialist physicians in a volatile malpractice environment, Defensive medicine: a culprit in spiking healthcare costs, Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study, Defensive medicine in U.S. spine neurosurgery, Personal consequences of malpractice lawsuits on American surgeons. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. Acquisition of data: Sankey. 2012 Feb 1;37(3):E188-94. Spine 18:18621866, 1993. 2014;96(4):266270. Use of the Airo mobile intraoperative CT system versus the O-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? Epstein NE. Summary of background data: Spine (Phila Pa 1976). Defendant-awarded cases by US region (right). Please enable it to take advantage of the complete set of features! Reviewed submitted version of manuscript: all authors. 2002;27(22):24252430. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. Kreisman Law Offices has been handling Illinois surgical error lawsuits for individuals and families for more than 35 years in and around Chicago, Cook County and surrounding areas, including Batavia, Bellwood, Deerfield, Evanston, Franklin Park, and Lansing. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. A total of 2724 screws were placed in 127 patients. Scarone P, Vincenzo G, Distefano D, et al. Disclaimer. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Spine 16(8 Suppl):S455458, 1991. 2017;31(3):287288. Spine 18:983991, 1993. 0 attorneys agreed. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. . Segal J. Unable to load your collection due to an error, Unable to load your delegates due to an error. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. HHS Vulnerability Disclosure, Help Thus, meaningful efforts to limit the rate of misplaced pedicle and lateral mass screws, such as the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation, should be carefully considered. Yuan et al 37 reported that the use of spinal instrumentation is associated with higher rate of infection (3%6%), neurologic injury (1%5%), instrumentation failure (6%10%), and reoperation (20%), compared with in situ arthrodeses.
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