25. An official website of the United States government. Pedicle screw placement accuracy impact and comparison between grading Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. Br J Neurosurg. Spine (Phila Pa 1976). All the incidental dural tears were repaired immediately and produced no clinical sequelae. Spine 18:23252326, 1993. Five patients had uneventful early postoperative course. 34. The defendants explanation provided an explanation for why Nyquists foot drop did not resolve after the misplaced screw was removed and shed doubt on the plaintiffs theory of liability. The site is secure. Can Postoperative Radiographs Accurately Identify Screw Misplacements? leg pain. Hardware-related failures were observed in 12 patients (10.7%). 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. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. PLoS One. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Disclaimer. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. Spine 6:263267, 1981. 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. Spine 13:952953, 1988. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. 4. $ = US$. In the other patient, L4L5 float arthrodesis was done. Similar to our findings, prior studies have shown that settlements result in lower payouts than cases that are ultimately taken to trial,7,14,15,30 with awards ranging from $125,000 to $9,000,000 compared to $134,000 to more than $38,000,000.7,15 Nevertheless, the true financial toll on spine surgery is largely unknown given that 85% of cases are dismissed or settled out of court, with undisclosed amounts.14 Likewise, substantial time is spent and costs, including legal and administrative, are incurred before judgment, as noted above. Jury Verdict for Doctor for Screw Allegedly Misplaced During Lumbar Elizabeth Hofheinz, M.P.H., M.Ed. Spine 15:1114, 1990. Malpractice liability and defensive medicine: a national survey of neurosurgeons. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. Pedicle screw insertion in the thoracolumbar spine. 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. Am J Otolaryngol. Epub 2021 Aug 28. Insuring spinal neurosurgery. Spine 8:970981, 1996. 15. It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. 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. Defensive medicine in neurosurgery: the Canadian experience. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). PDF Intraoperative biomechanics of lumbar pedicle screw loosening following Spine 14:472476, 1989. 5. Spine Deform. It has a great developing technique that is used for fixation and fusion in spine surgery. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. Neurosurgery. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. 2014;21(3):320328. 6. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. Per-patient analysis reveals more concerning numbers toward screw misplacement. Schatlo B, Molliqaj G, Cuvinciuc V, et al. 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. The .gov means its official. 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). Spinal fusion in the United States: analysis of trends from 1998 to 2008. Problems of balance were coronal (scoliosis greater than 5 or trunk shift greater than 5 mm) as seen on the AP radiograph taken with the patient standing or sagittal (failure to obtain or maintain lumbar lordosis). Fishers exact test and the Mann-Whitney U-test were used for the analysis of categorical and continuous data, respectively, except when an unpaired t-test was utilized for analyses related to normalized, nominal, and inflation-adjusted award totals. Hecht N, Kamphuis M, Czabanka M, et al. 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). 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. Careers. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. Each case was then carefully screened for relevance and sufficient data. 3. Smith TR, Hulou MM, Yan SC, et al. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. The rate of reoperation for screw misplacement per screw was 0.17%. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. This was followed by pseudarthrosis requiring revision surgery, present in 14.3% (n = 3) and 14.9% (n = 7) of plaintiff- and defendant-awarded cases, respectively (p = 0.99). 2020;162(6):13791387. Svider PF, Kovalerchik O, Mauro AC, et al. Although the rate of the reported medical complications was high (36.5%), these did not significantly affect the final clinical outcome of the current patients. Fortunately, most of the complications were minor and transient. Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted 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. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. Results: A total of 2724 screws were placed in 127 patients. Privacy Policy. A.J. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. Please try after some time. Clinical Orthopaedics and Related Research411:86-94, June 2003. Daniels AH, Ruttiman R, Eltorai AEM, et al. 13. Friedlander and Bradley will pay half of the $2.25 million. Partner, Paul M. da Costa, Obtains $4.5 Million Verdict - Snyder Sarno Please enable scripts and reload this page. 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. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. 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. The initial search using the terms above returned 3654 cases. 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. Open lumbar pedicle screw technique - Operative Neurosurgery 1). The third patient, who had central spinal stenosis, was treated by decompression alone. Comparison of pedicle screw placement accuracy between two types of 2014;20(2):196203. Spine (Phila Pa 1976). Eur Spine J. I won't be at the office but I will check my voice mail. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction 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. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. They both had motor deficits from which 1 patient recovered completely. 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). The medicolegal landscape of spine surgery: how do surgeons fare? 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%. Health Aff (Millwood). Accessibility Also notable, only one claim reported the use of intraoperative CT and was ultimately ruled in favor of the defendant. 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. Int Orthop 20:3542, 1996. 0 attorneys agreed. . 26. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. In four of these patients, bent screws occurred at 8 to 10 months after surgery; in three patients, broken screw necks were seen 1 year after surgery and in two patients, tulip screw plug dislodgments were observed at 4 and 6 months postoperatively, respectively. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. West III JL, Bradford DS, Ogilvie JW: Results of spinal arthrodesis with pedicle screw-plate fixation. 5. laterally placed screws and the azygous vein on the right (T5-T11). Lumbar Spine Surgery. Epstein NE. Defensive medicine: a culprit in spiking healthcare costs. Nottmeier EW, Seemer W, Young PM. Minimizing Pedicle Screw Pullout Risks: A Detailed Biomechan Routine CT scans were taken in all patients. Introduction. Dr. Abd-El-Barr is a consultant for Spineology. 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). Statistical analysis: Sankey. 2. Screw misplacement. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Copyright © 2023 Becker's Healthcare. None of these complications resulted in additional surgery or in a significant increase of morbidity. 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. 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. 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. 31. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. 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. Makhni MC, Park PJ, Jimenez J, et al. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. Ann Thorac Surg. 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. 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. In White AH, Rothman RH, Ray CD (eds). 27,30 Infected pseudarthrosis developed in one patient (0.9%) with an L4S1 arthrodesis, and the instrumentation was removed 18 months later resulting in a flat back syndrome. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. Studdert DM, Mello MM, Sage WM, et al. 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. 27. Spine 17:349355, 1992. Pedicle screw | definition of pedicle screw by Medical dictionary Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. 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. Arthrodesis was questionable in eight asymptomatic patients (7.1%). Methods. 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 Image intensification and the technique recommended by Weinstein et al 32 was used for screw placement in the lumbar vertebrae, whereas Chopin blocks (Medtronic Sofamor Danek) with two screws diverging bilaterally were used for sacral fixation. Spine 6:615619, 1981. Please enable it to take advantage of the complete set of features! 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. Your current browser may not support copying via this button. One of the common means of doing so is to place a screw into each of two adjacent spinal bones (vertebrae), and then a rod between them. EOS System Courtesy of EOS imaging. 10. 36. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). J Neurosurg Spine. 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). Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR 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. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Pullout performance comparison of pedicle screws based on cement Per-patient analysis showed 23 (18.11%) of patients had all screws AP. 21. Malpositioned pedicle screw resulting | Legal Advice - LawGuru A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. 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. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. J Neurosurg Spine. 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. Orthop Trans 11:99, 1987. 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. Plaintiff award amounts were adjusted for inflation as of April 2020 using an online inflation calculator provided by the US Bureau of Labor Statistics (https://www.bls.gov/data/inflation_calculator.htm). J Neurosurg Spine. A large number of studies have reported that in conventional thoracolumbar surgery, compared with traditional freehand screw placement, the accuracy of intraoperative pedicle screw placement has been improved with O-arm intraoperative navigation technology. 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. A p < 0.05 was considered statistically significant. 14. In the remaining patients, the standard construct was three-segment fixation spanning four vertebrae and three discs, two above and one below the fractured vertebra, using six screws. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. Svider PF, Husain Q, Kovalerchik O, et al. Spine (Phila Pa 1976). Din RS, Yan SC, Cote DJ, et al. Results. Pedicle screw placement is a common procedure. Are We Underestimating the Significance of Pedicle Screw Misplacement 16. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. 2014;174(11):18671868. 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. 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. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Rajasekaran S, Bhushan M, Aiyer S, et al. However, the highest offer had been a combined $300,000 from the two defendants. West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. 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. 33. 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 6 The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. All the operations were done by one surgeon (PK). Pedicle screws are used by spine surgeons as part of a fusion in which two adjacent bones in the spine are combined together as one. 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. matte black square deadbolt; roberts point park fishing report; qr code on binax covid test; mff premium character list. 2018;27(9):23392347. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. 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. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. 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.