pedicle screw misplacement malpractice

37. Study design: As compared to cases in 19952009, those in 20102019 resulted in a significantly higher average nominal payout to plaintiffs ($776,439 $74,460 vs $1,506,000 $385,527, p = 0.028). $2 Million Spinal Surgery Case Against Neurosurgeon and Hospital The states with the most cases included California (n = 10, 14.7%), New York (n = 6, 8.8%), Pennsylvania (n = 6, 8.8%), and Illinois (n = 5, 7.3%; Table 2). It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. However, published reports are increasingly demonstrative of the positive effect of pedicle fixation on arthrodesis and successful outcome in the treatment of patients with these disorders. West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. J Neurosurg. In the other patient, L4L5 float arthrodesis was done. 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. To prevent the development of pseudarthrosis, we think it is important for surgeons to apply the following five technical principles: the proper-sized pedicle screw has to be inserted on the first attempt; repeated manipulation in setting instruments must be avoided; anterior penetration of the screw into the sacrum and insertion of two screws in each side are advocated for fixing the lumbosacral junction; industrious and detailed decortication of the posterior elements must be developed fully; and the use of autologous bone graft is recommended. 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. Am J Otolaryngol. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. Despite this problem, the clinical result was excellent. Pedicle screw insertion in the thoracolumbar spine. 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. Balch CM, Oreskovich MR, Dyrbye LN, et al. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. The intent is to provide relief from pain and nerve damage. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Per-patient analysis reveals more concerning numbers toward screw misplacement. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. 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. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. 2014;20(6):636643. 2. Intraoperative pedicle fractures requiring further points of fixation. Neurosurgical practice liability: relative risk by procedure type. 2012;7(6):e39237. Despite commonly used, questions remain about their safety especially for the thoracic spine and in deformity where difficulty in positioning can lead to pedicle breach and adjacent structures injury. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. 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. 34. You are talking one of the most complicated area of the law. A p < 0.05 was considered statistically significant. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). 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. 2017;42(3):177185. Clinical Orthopaedics and Related Research, Get new journal Tables of Contents sent right to your email inbox, The Association of Bone and Joint Surgeons, Complications and Problems Related to Pedicle Screw Fixation of the Spine, Articles in Google Scholar by Pavlos Katonis, MD, Other articles in this journal by Pavlos Katonis, MD, Privacy Policy (Updated December 15, 2022). 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. An official website of the United States government. 2012;41(2):6973. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. Studies have shown that the greatest proportion of malpractice claims in spine surgery are related to procedural error,10,11,14,16,17,19 often resulting in the highest payouts.11,20 For spine surgery, one common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass screws, which occurs in approximately 14%55% of cases using standard techniques and results in neurological injury and/or durotomy in approximately 1%8% of cases.21 Misplaced screws have the potential to cause severe and sometimes permanent neurological deficits, including spinal cord and/or nerve root injury,21 as well as to decrease the stability of the fusion construct, leading to delayed complications related to pseudarthrosis. However, the misplacement of pedicle screws can lead to disastrous complications. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. The contact form sends information by non-encrypted email, which is not secure. Rajasekaran S, Bhushan M, Aiyer S, et al. 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. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. J Neurosurg Spine. J Neurosurg. Defensive medicine: a culprit in spiking healthcare costs. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. 8600 Rockville Pike Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. Li HM, Zhang RJ, Shen CL. Lawsuit information regarding the plaintiffs age at the time of the malpractice claim, sex, postoperative complaint, indication for index surgery, defendant surgeon specialty (neurosurgery vs orthopedics), and delayed diagnosis or treatment, as well as case location by state and case year, was obtained. Patient safety: disclosure of medical errors and risk mitigation. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. The patient had subsequent coronal imbalance and degeneration of the upper disc. (PDF) Lumbosacral pedicle screw placement using a fluoroscopic pedicle Spinal fusion in the United States: analysis of trends from 1998 to 2008. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. Problems at the junctions of the instrumented spine were seen in five patients (4.5%). 10. 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. For more information, please refer to our Privacy Policy. The rate of medical complications was 8%. From the *Department of Orthopaedic Surgery, University of Crete Medical School, Heraklion, Greece; and the **First Department of Orthopaedics, University of Athens Medical School, Athens, Greece. The amount awarded was not significantly different across US regions (p = 0.9; Fig. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. I won't be at the office but I will check my voice mail. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) In order to prove medical malpractice occurred, the plaintiffs attorney needs to show not only the plaintiff experienced a poor medical outcome, but that it was directly caused by medical negligence. Legal liability in iatrogenic orbital injury. Acta Neurochir (Wien). The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. 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. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Neurological outcome and management of pedicle screws - PubMed Thoracic pedicle screw placement: Free-hand technique - Bioline Five patients had uneventful early postoperative course. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. Malpractice issues in neurological surgery. matte black square deadbolt; roberts point park fishing report; qr code on binax covid test; mff premium character list. Author links open overlay panel Mohamad Bydon a b 1, Dimitrios Mathios a b 1, Mohamed Macki a b, Rafael De la Garza-Ramos a b, Nafi Aygun c, Daniel M. Sciubba a, Timothy F. Witham a, Ziya L. Gokaslan a b, Ali Bydon a b, Jean-Paul Wolinksy a. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. 2018;41(5):e615e620. Copyright © 2023 Becker's Healthcare. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. All Rights Reserved. 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. haroinfather roblox id Of note, the award amount for one settlement case was undisclosed. J Neurosurg Spine. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. 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. Spine 17:834837, 1992. Spine 8:970981, 1996. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. Forty-seven general complications were seen in 41 patients (36.5%). With pedicle shapes and sizes varying wildly in the scoliotic spine, misplacement of a screwas well as and under- or oversizingare real possibilities in spine surgery. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. PDF Intraoperative biomechanics of lumbar pedicle screw loosening following It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Don't jump in get legal help. Pedicle screw placement is a common procedure. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. JAMA. 32. Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. 3. Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. Epstein NE. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. 15. General complications were considered those developing during and after surgery that were not directly related to instrumentation. However, the misplacement of pedicle screws can lead to disastrous complications because of the close proximity to neural tissue and the surrounding vessels, although rare, serious complications have been reported, such as dural tear, nerve-root irritation, neural injury . 8. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. Thu, May 27th, 2021. pedicle screws sagittal alignment spinal fusion surgical guides Spinal fusion is used to treat a range of conditions associated with spinal column such as intervertebral disc degeneration and scoliosis [ 1 ]. Epstein NE. 33. The average followup was 35 months (range, 1851 months). Pedicle screw placement: Robotic assistance for greater precision 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. 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 2021 Jul 1;41(Suppl 1):S80-S86. St Louis, CV Mosby 322327, 1987. 5 Those authors recommend that particular care should be taken in inserting the washers without cross threading and ensuring that they are locked down tightly, with an adequate length of rod protruding beyond the screw. * Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. Neurosurgery. We also investigated the effect of bone mineral density (BMD), diameter of pedicle screws, and the region of spine on the pullout strength of pedicle screws. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. Pedicle screw insertion techniques: an update and review of the 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. Analysis and interpretation of data: Sankey, TT Than. Spine 19:25842589, 1994. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. 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. Bydon M, Xu R, Amin AG, et al. 7. 5. Open lumbar pedicle screw technique - Operative Neurosurgery Hardware problems were those related to the physical change of metal and screw position. The medicolegal landscape of spine surgery: how do surgeons fare? Patient-specific 3D-printed surgical guides for pedicle screw insertion Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. 2020;11:38. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. J Pediatr Orthop. None of these complications resulted in additional surgery or in a significant increase of morbidity. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. Whitecloud et al 35 reported an overall 45% rate of minor and major complications, with the rate of complications increasing to 63% in patients who had previous lumbar surgery. 2011;213(5):657667. The third patient, who had central spinal stenosis, was treated by decompression alone. pedicle screw misplacement malpractice Spine (Phila Pa 1976). Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. were excluded from analysis. Robotic-assisted pedicle screw placement fails to reduce overall On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. And while the offending screw was removed the next day, Nyquist continued to experience right foot drop, along with lower back pain and sciatica, i.e. 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. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. J Neurosurg Spine. Am J Transl Res. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. 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. Each case was then carefully screened for relevance and sufficient data. Deyo RA, Mirza SK, Martin BI. 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. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. Pullout performance comparison of pedicle screws based on cement Before Clin Orthop 115:130139, 1976. 2018;28(2):186193. 1. In several of the studies in the spinal literature, the contention that instrumentation improves arthrodesis rates, considering that nonunion contributes to a poor outcome in spinal arthrodesis is favored. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. One hundred twelve consecutive patients were entered into a retrospective study of instrumented thoracolumbar, lumbar, and lumbosacral spinal arthrodesis at our institution, between September 1994 and January 1999. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. Axial lumbar CT scans demonstrating both laterally (right) and medially (left) misplaced pedicle screws, resulting in pedicle and transverse process fractures (A) and canal compromise (A and B). Per-patient analysis showed 23 (18.11%) of patients had all screws AP. MeSH The cost of defensive medicine on 3 hospital medicine services. Med Econ. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. In our opinion, these problems may be prevented by applying the following principles: limitation of spine arthrodesis to the pathologic levels, inclusion of already extensive changes at the level above or below the planned arthrodesis into the arthrodesis, restoration of postoperative sagittal and coronal alignment, and avoidance of impingement syndrome from the adjacent nonfused facets. Potential complications may include increased pain, infection, or mechanical . Spinal fusion procedures are increasingly performed each year, with Deyo et al. You may be trying to access this site from a secured browser on the server. To prevent general complications, it is evident that precise and careful soft tissue handling, proper irrigation, and debridement during and after surgery, decrease of operative time, and proper patient monitoring postoperatively must be done. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. However, the misplacement of pedicle screws can lead to disastrous complications. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. Your message has been successfully sent to your colleague. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. A.J. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. Schatlo B, Molliqaj G, Cuvinciuc V, et al. Back pain/spinal stenosis and neurogenic claudication/radiculopathy were the most frequently reported indications for the index surgery, accounting for 13 (19.1%) and 11 (16.2%) cases, respectively. Accuracy of pedicle screw placement and clinical outcomes of robot-assisted technique versus conventional freehand technique in spine surgery from nine randomized controlled trials: a meta-analysis.

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