pedicle screw misplacement malpractice pedicle screw misplacement malpractice

When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. Spine 24:23522357, 1999. You may be trying to access this site from a secured browser on the server. Disclaimer. PMC Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). The largest inflation-adjusted payout awarded to the plaintiff ($3,372,185) for nerve root injury occurred in a 36-year-old male who had undergone an L4S1 posterior spinal fusion, which resulted in permanent and direct injury to right L5 and S1 nerve roots, with foot drop and radiculopathy. Over 40% of patients had screws with either some/major concern. . Statistical analysis: Sankey. J Spine Surg. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. 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. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. Plaintiff-awarded cases by US region (left). Each side was judged separately. Two-dimensional (2D) fluoroscopy-guided percutaneous pedicle screw (PPS) placement is currently the most widely applied instrumentation for minimally invasive treatment of spinal injuries requiring stabilization. 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. The highly litigious environment within healthcare has resulted in a majority of physicians practicing defensive medicine,15 often leading to burnout6,7 and an exorbitant ethical and financial burden on medical and surgical care.7,8 In 2008, medical liability accounted for $55.6 billion, representing 2.4% of the United States (US) healthcare expenditures that year,5,7,9,10 and the pervasive practice of defensive medicine may cost up to $210 billion annually in the US.5 A similar trend has been observed in Europe.11, Neurosurgery is the specialty most frequently affected by lawsuits and the fear of litigation, both in the US and abroad,12 with spine surgery at the forefront.11,1317 As a result, spine surgeons are nearly three times more likely than nonspine surgeons to practice defensive medicine, defined as the avoidance of high-risk procedures and the provision of unnecessary services and assessments beyond what is clinically necessary in an effort to avoid litagation.5 The average time to judgment in a case is approximately 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 As a result, physicians spend an average of 11% of their careers dealing with one or more open malpractice claims.18 Neurosurgeons are especially impacted, spending an average of 27.2% of their careers in an open lawsuit.10. 3. Med Econ. Hardware problems were those related to the physical change of metal and screw position. In White AH, Rothman RH, Ray CD (eds). I won't be at the office but I will check my voice mail. Clin Orthop 115:130139, 1976. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. 38. 5. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. Notwithstanding these concessions, the MDU argued that misplacement of pedicle screw tracts was common in surgery of this kind, even in experienced and competent hands. Lali Sekhon, Jocelyn Idema & more: 4 spine and neurosurgeons making headlines, Spinal cord stimulation trumps medication for pain reduction 7 takeaways, Dr. Khalid Kurtom on major trends in spinal cord injury surgery. 2014;20(6):636643. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. 2020;11:38. Please enable it to take advantage of the complete set of features! 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. These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. 2012;21(suppl 2):S196S199. Call me tomorrow. St Louis, CV Mosby 322327, 1987. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. 2006;65(4):416421. To investigate intraoperative reinsertion of percutaneous pedicle screw (PPS) with intraoperative CT-based navigation and to evaluate the rate of deviation of PPS at postoperative radiographic examination. were excluded from analysis. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . 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. concluded that the robot-assisted technique was significantly more accurate than the traditional freehand technique.39 Despite the learning curve and initial cost of obtaining technologies such as 3D fluoroscopic devices, intraoperative CT, or robotic navigational systems, the routine use of these technologies for intraoperative imaging confirmation and potential revision of misplaced screws may help spine surgeons avoid inadvertent iatrogenic morbidity for their patients and potential litigation. Despite these failures, solid spinal arthrodesis was obtained in all patients. 8,24,25,32. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). (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. Clin Orthop 203:4553, 1986. Neurosurgery. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. 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. Bookshelf All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. Categorical and continuous data are described as frequency (percentage) and median (interquartile range), respectively, except for the use of mean standard deviation for award amounts since both nominal and inflation-adjusted award totals passed (alpha = 0.05) the DAgostino-Pearson omnibus normality test. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. Ann Thorac Surg. You are talking one of the most complicated area of the law. All Rights Reserved. Nominal and inflation-adjusted award payouts were higher for trial verdicts than for settlement/arbitration, with a nominal average of $1,140,473 $841,683 versus $788,533 $306,186 awarded to the plaintiff, respectively (p = 0.30). 2012 Feb 1;37(3):E188-94. 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. At the trials close, the plaintiffs attorney had asked the jury to return a $5.3 million verdict and had made a prior demand to settle the medical malpractice lawsuit for $1 million. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. All Rights Reserved. Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt 2021 Jul 1;41(Suppl 1):S80-S86. J Neurosurg Spine. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) EOS System Courtesy of EOS imaging. Accuracy of pedicle screw insertion by AIRO intraoperative CT in complex spinal deformity assessed by a new classification based on technical complexity of screw insertion. A retrospective review of charts, XRs and low-dose CT scans of 127 patients who underwent spinal fusion with pedicle screws for spinal deformity was performed. Procedural errors led to combined payouts totaling $124,943,933 in neurosurgery claims between 2003 and 2012 in a study looking at data from the Physician Insurers Association of America Data Sharing Project.10 However, our study is the first to report the direct medicolegal impact of screw misplacement on US spine surgery, with 30.9% of judgments/settlements in favor of the plaintiff, resulting in average payouts of $1,204,422 $753,832 per claim. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. Spine J. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. Moffatt-Bruce SD, Ferdinand FD, Fann JI. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. Spine 13:10121018, 1988. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. We attribute the 24.1% disc space narrowing in the instrumented segments mainly to the severe injury of the disc and communication of the end plate in burst fractures, which could accelerate the disc degeneration and narrowing. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 things to know Spine Monday, May 7th, 2018 Post Listen Text Size On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. 2 One of the first obstacles regarding . 21. In five patients with thoracolumbar injuries, who were the first treated in the current series, and in four patients with fractures in the lower lumbar spine, two-segment fixation was used. 37. Surg Neurol Int. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. and 17.1% of the patients included had at least one screw misplaced. Legal liability in iatrogenic orbital injury. Pullout performance comparison of pedicle screws based on cement application and design parameters Tolga Tolunay, Cemile Bagl, Teyfik Demir, Mesut E Yaman, and Arslan K Arslan Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 2015 229: 11 , 786-793 Download Citation L3S1 spine arthrodesis was done in the first patient but the correction of scoliosis was not sufficient and coronal imbalance persisted after surgery, which accelerated the degeneration of the level just above the arthrodesis. 3). Study design: Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. The suit claimed Dr. Friedlander failed to diagnose and treat the mispositioned screw in a timely manner, leading the plaintiff to develop pain in his right leg, numbness in his right calf and weakness in his right toes. 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. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. The majority of screws were misplaced in the lumbar spine for both plaintiff- and defendant-awarded cases (66.7% vs 57.4%, respectively, p = 0.564; Table 1). 0 attorneys agreed. 35. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. All the incidental dural tears were repaired immediately and produced no clinical sequelae. Elizabeth Hofheinz, M.P.H., M.Ed. 29. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. While the majority of claims are found to lack merit, resulting in a verdict in favor of the defendant or case dismissal,7,1316 at least 37% are considered valid.26 Regardless, payouts to plaintiffs are often substantial, averaging in the hundreds of thousands to millions of dollars in both the US and Europe.10,11,14,17,20 Communication of errors and expectations, thorough documentation, and selection of appropriate patients and surgical indications have been shown to reduce the likelihood of a successful malpractice claim.13,16,27,28 In addition, attempts at tort reform in some states have helped limit the financial burden of medical malpractice payouts through methods such as capitation.16,20,22,26 However, efforts to limit malpractice claims in the first place are greatly needed. The median time to case closure was 56.3 (35.267.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.477.2) months for defendant (surgeon) verdicts (p = 0.117). Most of these complications were minor and with the exception of two misplaced screws, did not contribute to the occurrence of neurologic impairment or severe pain. Characteristics of medicolegal cases related to misplaced screws in spine surgery. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. Spine 16(8 Suppl):S455458, 1991. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. Spine fixation included one segment in 27 patients, two segments in 38 patients, three segments in 42 patients, and more than three segments in five patients. 2. reporting that the number of Medicare patients who underwent a complex lumbar spine fusion for spinal stenosis increased 15-fold, from 1.3 persons per 100,000 Medicare persons in 2002 to 19.9 in 2007.31 Similarly, a study by Rajaee et al. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. N Engl J Med. Conception and design: Sankey, KD Than. The accuracy of pedicle screw placement using intraoperative image guidance systems. Two patients with associated injuries in the lower limbs had deep venous thrombosis develop, three patients had pneumonia develop, and four patients with neurologic impairment had urinary tract infections develop. Importantly, these advanced technologies are not always readily available or the standard of care and cannot supplant a thorough understanding of operative anatomy, a high-quality surgical technique, and general complication-avoidance measures. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. 24. Call Us Now For a Free Consultation | Toll Free: 800.583.8002 | Local: 312.346.0045, Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants , Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation , Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in, $75 Million Jury Verdict in Failure to Timely Diagnose Stroke, $18 Million Jury Verdict in Late Diagnosis of Breast Cancer, $300,000 Settlement for Excessive Use of Radiation, Chicago Medical Malpractice Lawyer Kreisman Law Offices Home, Contact Illinois Personal Injury Attorney Kreisman Law Offices. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. Li HM, Zhang RJ, Shen CL. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Balch CM, Oreskovich MR, Dyrbye LN, et al. Ahmadi SA, Sadat H, Scheufler KM, et al. 9. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. your express consent. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. Furthermore, 25 patients (22.3%) reported persistent pain in the iliac crest (donor graft site) for several months, for which they were treated with repeated lidocaine injections and analgesics. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. Materials and Methods Sixty . The average age of the patients was 47 years and the average followup was 35 months. 2007;106(6):11081114. While reported to be one of the best legal research resources available and utilized in several previous studies,7,14,16,23,24 available court documents and clinical/operative details are highly variable and greatly limited among case files. 1. 2013;32(1):111119. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Ultimately, additional prospective, multiinstitutional large-volume studies are needed to validate these findings, and future studies should evaluate the long-term impact on the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation on the frequency and success of malpractice claims related to misplaced pedicle and lateral mass screws. A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. Reviewed submitted version of manuscript: all authors. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. 1. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. In the current study, the arthrodesis rate of 89.4% compares favorably with other previously reported series in the spinal literature, most of which use radiographic means to access the status of the spinal arthrodesis. 2012;89(10):7071. Several studies reveal that fusion rates increase when rigid internal fixation is used, 14,20,21,33,38 and that by using pedicle screws and plates or rods for stabilization, spinal arthrodesis can be limited to the disease segments. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. In this example, the surgeon replaced the misplaced screw prior to leaving the operating room, which arguably played a significant role in the jury ruling in favor of the defendant (surgeon). The rate of reoperation for screw misplacement per screw was 0.17%. J Spinal Disord Tech. 1). Spine (Phila Pa 1976). The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. The rate of misplaced pedicle screws ranges from 1.1% to 28.8%, 10 although neurologic injury from misdirected pedicle screws has been reported to occur in 0% to 12% of patients. It argued that the foot drop was unavoidable and due to the surgeons need to manipulate the right L5 nerve root in order to remove Nyquists herniated disc during the spinal fusion surgery. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma.