pedicle screw misplacement malpractice10 marca 2023
These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. 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). 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. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. Friedlander and Bradley will pay half of the $2.25 million. 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. Li HM, Zhang RJ, Shen CL. 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. In the current study, only five patients with junction problems above the instrumented area were observed with the following probable predisposing factors: an already degenerative disc, coronal imbalance, very long arthrodesis, and old age. Am J Orthop. 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. Level of evidence: Pitfall: Unstable injuries. Unable to load your collection due to an error, Unable to load your delegates due to an error. 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. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. Please try after some time. 2019;19(7):12211231. Call me tomorrow. N Engl J Med. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. Wolters Kluwer Health 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. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. 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). Epub 2014 Apr 4. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). Pedicle screw insertion in the thoracolumbar spine. Review of neurosurgery medical professional liability claims in the United States. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Spine 15:1114, 1990. 5. 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. 2002;27(22):24252430. Several studies have shown that spine surgery is at the highest risk for litigation among the surgical subspecialties.12,29 The majority of claims are related to technical and procedural errors,29 including misplaced pedicle and/or lateral mass screws. 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. doi: 10.1097/BPO.0000000000001828. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. 2014;21(3):320328. 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. Spine 18:11601172, 1993. 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. All Rights Reserved. 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. Guillain A, Moncany AH, Hamel O, et al. 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. Nottmeier EW, Seemer W, Young PM. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. 39. 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. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Would you like email updates of new search results? 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. Your current browser may not support copying via this button. Nayar G, Blizzard DJ, Wang TY, et al. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. 14. Clipboard, Search History, and several other advanced features are temporarily unavailable. Five patients had uneventful early postoperative course. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Arthrodesis was questionable in eight asymptomatic patients (7.1%). 37. The authors of the current study aimed to describe this impact in the United States, as well as to suggest a potential method for mitigating the problem. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. The incidence of screw failure, which can occur despite solid arthrodesis, 7 in the current series was 8% and mainly involved patients with thoracolumbar injury. Laryngoscope. 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). A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. The amount awarded was not significantly different across US regions (p = 0.9; Fig. Thu, May 27th, 2021. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. J Bone Joint Surg 62A:13021307, 1980. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. 4). This site needs JavaScript to work properly. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Federal government websites often end in .gov or .mil. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. 2006;65(4):416421. Results. Cookie Policy. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. You may be trying to access this site from a secured browser on the server. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. 31. 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. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. 3). $ = US$. Despite these failures, solid spinal arthrodesis was obtained in all patients. 2020;162(6):13791387. 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. Malpractice risk according to physician specialty. 2013;32(1):111119. National Library of Medicine 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. 2012 Feb 1;37(3):E188-94. Administrative/technical/material support: Mehta, Wang, KD Than. The site is secure. Smith TR, Hulou MM, Yan SC, et al. Statistical analysis: Sankey. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. West III JL, Bradford DS, Ogilvie JW: Results of spinal arthrodesis with pedicle screw-plate fixation. Conception and design: Sankey, KD Than. (%), Pseudarthrosis requiring revision surgery. There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. J Neurosurg. Rovit RL, Simon AS, Drew J, et al. 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 majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. Neurosurgical practice liability: relative risk by procedure type. Routine CT scans were taken in all patients. pedicle screw misplacement malpractice. Before The third patient, who had central spinal stenosis, was treated by decompression alone. Figure 1: Lower thoracic pedicles provide the firm purchase of the pedicle screw from a lateral starting point and 10-15 degrees convergent angle Surgical technique "Free Hand" pedicle screw placement [50] Our "Free Hand" technique is equivalent for lumbar and J Neurosurg Spine. Zdeblick 38 also reported an overall arthrodesis rate of 65% in patients without instrumentation, 77% in patients with semirigid fixation, and 95% in patients with a rigid constrained screw-rod system. 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. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Epub 2022 Oct 29. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. 3. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. 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. 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. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. Lumbar Spine Surgery. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. 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. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). 2,24,28,36. 2012;37(1):6776. 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. Neurosurgeons and orthopedic surgeons were named as the defendant in an equal number of cases, and the decision for the plaintiff versus the defendant was also similar between specialties. Spine J. 4. 2021 Jul 1;41(Suppl 1):S80-S86. Steffee AD, Brantigan JW: The variable screw placement spinal fixation system: Report of a prospective study of 250 patients enrolled in Food and Drug Administration clinical trials. George Sapkas, MD, DSc; and Panayiotis J. 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It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. 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. 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. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. A total of 69 patients (mean age, 67.416 . 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. 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. 13. The pedicle screw system is widely used in spine surgery, and it provides rigid fixation and leads to successful subsequent deformity correction and bony fusion. Clin Orthop 203:7598, 1986. 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. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Elizabeth Hofheinz, M.P.H., M.Ed. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Spine (Phila Pa 1976). 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. J Bone Joint Surg 54A:11951204, 1972. 6 The rate of reoperation for screw misplacement per screw was 0.17%. The cost of defensive medicine on 3 hospital medicine services. 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. Bethesda, MD 20894, Web Policies In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. A high-low agreement is a settlement in which a defendant agrees to pay the plaintiff a minimum recovery in exchange for the plaintiff agreeing to accept a maximum amount regardless of the trial's outcome. single homes for sale in lehigh valley, pa single homes for sale in lehigh valley, pa Home Realizacje i porady Bez kategorii single homes for sale in lehigh valley, pa Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). Your message has been successfully sent to your colleague. Hardware-related failures were observed in 12 patients (10.7%). 8. 3. were excluded from analysis. Preparation. Malpractice issues in neurological surgery. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. Personal consequences of malpractice lawsuits on American surgeons. JAMA Intern Med. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. Analysis and interpretation of data: Sankey, TT Than. 17. In addition, hardware failures were observed in 12 patients (10.7%), junctional problems were seen in five patients (4.5%), problems in the instrumented segments were seen in 39 patients (34.7%), and problems of balance occurred in five patients (4.5%). One hundred four of the 112 patients had a posterior procedure. Methods. 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. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. 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 ]. 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.
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