pedicle screw misplacement malpractice

26 They support that after a lengthy symptom-free period, segments next to a fused segment can break down and the segment next to the adjacent segment is almost as likely to break down as the adjacent segment. (%), Pseudarthrosis requiring revision surgery. The plaintiff received $2.4 million for pain and suffering and loss of enjoyment of life, $2 million for lost income and approximately $123,000 for medical expenses. Statistical analysis: Sankey. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. 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. 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. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Sethi MK, Obremskey WT, Natividad H, et al. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. government site. Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. Although the rationale for using pedicle screw fixation is fairly clear, controversy continues regarding the application of pedicle instrumentation for spine arthrodesis, especially on the degenerative lumbar spine. J Bone Joint Surg 61A:201207, 1979. 1. Malpractice issues in neurological surgery. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. 2013;34(6):699705. 2,24,28,36. Malpractice risk according to physician specialty. This patient recovered completely in 6 weeks. 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Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Many technological advances have been made over the past several decades in an effort to improve the accuracy of screw placement in spine surgery.3436 For example, 3D fluoroscopybased image guidance has been shown to decrease the pedicle breach rate in several studies compared to the rate with 2D fluoroscopic guidance or the freehand technique, particularly in deformity and revision surgeries.21,34,36,37 CT guidance or intraoperative confirmation has also been shown to further improve the accuracy of pedicle screw placement,3638 with reported accuracy rates of 89%100% reported in the literature, depending on the authors breach criteria.35 However, it is important to note that the use of this technology is often accompanied by a lower threshold for intraoperative screw revision, sometimes leading to higher rates of replaced screws.33 Arguably, these improved trajectories may avoid iatrogenic neurological deficits due to prolonged nerve root compression or even improve the stability of the construct;34,37 however, prospective studies of long-term outcomes and rates of revision surgery remain sparse in the literature. Insuring spinal neurosurgery. Conversely, Nyquists foot drop did not resolve after the screw was removed, which begged the question of whether the foot drop was in fact caused by the misplaced screw. While the majority of verdicts are found in favor of the defendant (surgeon), over 30% of cases in this study were found in favor of the plaintiff (patient), resulting in average inflation-adjusted payouts of over $1.2 million per claim over the past 25 years. J Neurosurg. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). to maintaining your privacy and will not share your personal information without Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. Pedicle screw placement accuracy using ultra-low radiation imaging with image enhancement versus conventional fluoroscopy in minimally invasive transforaminal lumbar interbody fusion: an internally randomized controlled trial. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. 15. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. This device was used with an early version of the Cotrel-Dubousset instrumentation to provide sacral fixation and it is rarely used since the more widespread use of newer spine fixation systems. Studdert DM, Mello MM, Sage WM, et al. Problems at the junctions of the instrumented spine were seen in five patients (4.5%). Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . Spine 18:983991, 1993. However, this difference was no longer significant when adjusted for inflation ($1,016,000 $90,875 vs $1,630,000 $422,405, p = 0.09). Defensive medicine in neurosurgery: the Canadian experience. 2017;42(3):177185. Results: A total of 2724 screws were placed in 127 patients. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. 29. 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. 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. The literature gave a range of screw misplacement rates detected on postoperative imaging of between 1% and 18%, with the rate generally considered to be around 10%. Epstein NE. 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. Clin Orthop 203:4553, 1986. One hundred four of the 112 patients had a posterior procedure. Except for the patient with an infected pseudarthrosis who had a flat back syndrome (sagittal imbalance) develop, coronal imbalance was observed in five patients (4.5%), and ranged from 7.5 to 12 (Fig 3). Dr. Friedlander did not order a CT or MRI until January 2013, when the pedicle screw was found to be in the wrong location and a failed fusion was diagnosed, according to the suit. were excluded from analysis. 2016;102(2):358362. Privacy Policy. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. EOS System Courtesy of EOS imaging. Epstein NE. 2012;7(6):e39237. 13. Defensive medicine: a culprit in spiking healthcare costs. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. The link was not copied. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Drs. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. 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 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). Of note, the award amount for one settlement case was undisclosed. demonstrated that the number of hospital discharges for spinal fusion increased 2.4 times (137%) from 174,223 to 413,171 (p < 0.001) between 1998 and 2008.32 The true frequency of malpositioned pedicle and lateral mass screws is likely underestimated in spine surgery given the fact that the majority of misplaced screws, as well as the potential complications related to them, are not reported in practice and may be clinically silent. Dr. Shaffrey has received grants from the NIH and Department of Defense. All the operations were done by one surgeon (PK). However, this is the first study to evaluate the direct medicolegal impact of misplaced pedicle and lateral mass screws on spine surgery in the US and presents important information that may support the routine use of intraoperative imaging confirmation (via 3D fluoroscopy or intraoperative CT) and/or navigated screw placement (either computer- or robot-assisted) as a potential method to decrease the risk of future litigation during spinal fusion procedures. Spine (Phila Pa 1976). Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. Administrative/technical/material support: Mehta, Wang, KD Than. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. Din RS, Yan SC, Cote DJ, et al. 3). Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Nayar G, Blizzard DJ, Wang TY, et al. Preparation. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. Spine 13:952953, 1988. 34. 5-7 Materials and Methods This is a retrospective study of kyphotic spondylitis tuberculosis (Stb) patients conducted at Fatmawati General Hospital, Jakarta, Indonesia, through the year 2020-2021. Mason A, Paulsen R, Babuska JM, et al. doi: 10.1097/BPO.0000000000001828. 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. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. Taylor CL. 2011;365(7):629636. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. Bydon M, Xu R, Amin AG, et al. South Med J 62:17, 1969. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. To reinforce spinal fixation, we have proposed a construct with segmental pedicle fixation two levels above and one level below the injured level and insertion of a screw deep into the pedicle, providing more contact area between screw head and bone and reducing the moment arm of the bending stress. Dr. Abd-El-Barr is a consultant for Spineology. 17,18,31,39 Edwards 6 showed that solid arthrodesis developed in 96% of patients without previous surgery, whereas 84% of patients having secondary operations experienced a similar result. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. Methods. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. You may be trying to access this site from a secured browser on the server. The .gov means its official. Wolters Kluwer Health 11. Don't jump in get legal help. Orthopedics. Clin Orthop 203:717, 1986. Clipboard, Search History, and several other advanced features are temporarily unavailable. The cost of defensive medicine on 3 hospital medicine services, Defensive medicine in neurosurgery: the Canadian experience, Review of neurosurgery medical professional liability claims in the United States, A nine-year review of medicolegal claims in neurosurgery, Malpractice risk according to physician specialty, Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003, Descriptive analysis of state and federal spine surgery malpractice litigation in the United States, Malpractice litigation following spine surgery, Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis, Malpractice claims in spine surgery in Germany: a 5-year analysis, On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim, Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England, Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort, It is easier to confuse a jury than convince a judge: the crisis in medical malpractice, Determining legal responsibility in otolaryngology: a review of 44 trials since 2008, Legal liability in iatrogenic orbital injury, Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study, Malpractice issues in neurological surgery. Additional survey data have shown that 50% of physicians exhibit at least a temporary loss of self-esteem after a malpractice claim, and at least 25% experience depression.22 As stated above, the average neurosurgeon spends 27.2% of his or her entire career in an open malpractice claim,10 and each case can take an average of 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 Likewise, neurosurgeons have a higher risk than practitioners in other specialties of being named in multiple malpractice suits given the particularly high-risk nature of the specialty.10 Even when found in favor of the defendant (surgeon), each case ultimately takes a substantial emotional and financial toll on the physician(s) involved. However, we did not observe any screw breakage in patients with a degenerative lumbar spine, and the absence of broken screws in this series is because arthrodesis in almost all patients occurred in situ. 8600 Rockville Pike All case demographics are summarized in Table 1. Each case was then carefully screened for relevance and sufficient data. Characteristics of medicolegal cases related to misplaced screws in spine surgery. Reviewed submitted version of manuscript: all authors. 2013;32(1):111119. Eur Spine J. J Neurosurg Spine. Conclusion: 5. 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. Patient safety: disclosure of medical errors and risk mitigation. 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. Over 40% of patients had screws with either some/major concern. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. 2014;20(2):196203. 2021 Jul 1;41(Suppl 1):S80-S86. Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). 2017;27(4):470475. In addition, studies have shown that over 85% of malpractice claims are either dismissed or settled out of court,14 which likely results in a high degree of underreporting. Show more. Hardware-related failures were observed in 12 patients (10.7%). George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison.

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pedicle screw misplacement malpractice