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2017;31(3):287288. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. 29. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. Spine 6:263267, 1981. Int Orthop 20:3542, 1996. Show more. Clipboard, Search History, and several other advanced features are temporarily unavailable. 27. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. 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. 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. Moreover, local court rulings are not included in the Westlaw Edge database; however, this is unlikely to present meaningful bias given that malpractice claims are generally filed in state courts. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. 2006;65(4):416421. 2014;21(3):320328. Ann R Coll Surg Engl. Each case was then carefully screened for relevance and sufficient data. Please enable scripts and reload this page. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 26. Through the use of expert witness testimony, Mr. da Costa was able to prove to the jury that by misplacing the pedicle screw during the surgery, and failing to timely diagnose and correct the malpositioned screw, Defendants deviated from accepted standards of care. Spine 13:952953, 1988. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. 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. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. Privacy Policy. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). may email you for journal alerts and information, but is committed Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. 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Reviewed submitted version of manuscript: all authors. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. 11. Seven hundred sixty-three screws were inserted in 138 patients. 2014;20(2):196203. 7. (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. Li HM, Zhang RJ, Shen CL. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Moreover, several cases stated that the surgeon used only the anteroposterior or the lateral view, but not both, and the plaintiffs counsel used this information in support of their claim. 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. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. 2019;19(7):12211231. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Dr. Shaffrey has received grants from the NIH and Department of Defense. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. The most frequent primary injury listed for a lawsuit was nerve root injury, present in 81.0% (n = 17) and 74.5% (n = 35) of plaintiff- and defendant-awarded cases, respectively (p = 0.7). Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. Din RS, Yan SC, Cote DJ, et al. Facebook Google Plus Youtube RSS Email. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. None of these complications resulted in additional surgery or in a significant increase of morbidity. Despite these failures, solid spinal arthrodesis was obtained in all patients. 37. Spine 18:23252326, 1993. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. 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. Epstein NE. 31. Segal J. The third patient, who had central spinal stenosis, was treated by decompression alone. Todd NV. 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. The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Thankfully, most screws are just misplaced by a millimeter or two out the front or are slightly off medially, so they are not doing real damage. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. However, the misplacement of pedicle screws can lead to disastrous complications. Thu, May 27th, 2021. Spine (Phila Pa 1976). Dr. Shaffrey holds patents with, receives royalties from, and is a consultant for Medtronic, NuVasive, and Zimmer Biomet; is a stockholder in NuVasive; is a consultant for K2M, Stryker, SI Bone, and In Vivo; and has received grants from the ISSG, DePuy Synthes, and AO Spine. It is indicated that screws medially misplaced at a distance greater than 2-mm, especially 4 mm, may be a cause of negative effects on the neural structure and should be removed during the early phase of the postoperative period, even among patients without postoperative neurological abnormalities. The patient had subsequent coronal imbalance and degeneration of the upper disc. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. 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. 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). When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. 144 (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. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). J Bone Joint Surg 73A:11791184, 1991. 2017;42(3):177185. 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. 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. 2011;306(10):1088. Malpractice issues in neurological surgery. 8,24,25,32. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. The patient suffered permanent nerve damage as a result of the puncture. The plaintiff underwent revision surgery in May 2013. 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. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. 2014;96(4):266270. 35. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. 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. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Per-patient analysis reveals more concerning numbers toward screw misplacement. The medicolegal landscape of spine surgery: how do surgeons fare? Roy-Camille R, Roy-Camille M, Demeulenaere C: Osteosynthese du rachis dorsal, lombaire et lombo-sacre par plaque metalliques vissees dans les pedicules vertebraux et es apophyses articularies. were excluded from analysis. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Neurologic injury. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. your express consent. 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). 2012;37(1):6776. Orthopedics. 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. I won't be at the office but I will check my voice mail. Neurosurgical practice liability: relative risk by procedure type. Taylor CL. laterally placed screws and the azygous vein on the right (T5-T11). Neurosurgery. Screw misplacement. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. Spine 19(20 Suppl):2279S2296, 1994. 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. The medicolegal landscape of spine surgery: how do surgeons fare? Elizabeth Hofheinz, M.P.H., M.Ed. 36. General complications were considered those developing during and after surgery that were not directly related to instrumentation. Of note, the award amount for one settlement case was undisclosed. Clin Orthop 203:7598, 1986. A total of 2724 screws were placed in 127 patients. 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. 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. Friedlander and Bradley will pay half of the $2.25 million. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. The cost of defensive medicine on 3 hospital medicine services. 8. Clin Orthop 115:130139, 1976. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 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. Lehmann TR, LaRocca HS: Repeat lumbar surgery: A review of patients with failure from previous lumbar surgery treated with spinal canal exploration and lumbar spine fusion. 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. 18. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults, Spinal fusion in the United States: analysis of trends from 1998 to 2008, Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws, The accuracy of pedicle screw placement using intraoperative image guidance systems, 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, 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, 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, Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO, 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, Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison, Verdict/Settlement Search and Inclusion/Exclusion Criteria, Plaintiff Claim and Index Surgery Information, Impact of Medical Malpractice on Neurosurgeon and Orthopedic Surgeon Careers, Financial Burden of Medical Malpractice Claims Related to Misplaced Pedicle and/or Lateral Mass Screws, Frequency of Misplaced Pedicle and Lateral Mass Screws in Spine Surgery, Strategies to Improve the Accuracy of Screw Placement in Spine Surgery, Top 25 Cited Gamma Knife Surgery Articles - Trigeminal Neuralgia, Top 25 Cited Gamma Knife Surgery Articles - Volume 111, https://doi.org/10.3171/2020.8.FOCUS20600, https://www.bls.gov/data/inflation_calculator.htm, Volume 49 (2020): Issue 5 (Nov 2020): Medicolegal issues in neurosurgery, Single vs multiple misplaced screw(s), no. Fager CA. 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. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Spine (Phila Pa 1976). Of the 112 patients, 57 patients had a lumbar degenerative disorder, (lumbar degenerative spinal canal stenosis in 23 patients, degenerative or spondylolytic spondylolisthesis in 12 patients, postlaminectomy instability or stenosis in 20 patients, and recurrent disc prolapse in two patients), 42 patients had spinal cord injury, eight patients had infection, and five patients had a spinal tumor (Table 1). J Am Coll Surg. Over 40% of patients had screws with either some/major concern. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. Sethi MK, Obremskey WT, Natividad H, et al. 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. 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).