pedicle screw misplacement malpractice

Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. 2014;96(4):266270. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. A.J. However, the misplacement of pedicle screws can lead to disastrous complications. 2005;293(21):26092617. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . Malpractice liability and defensive medicine: a national survey of neurosurgeons. 3. Epub 2014 Jun 13. 2018;18(2):209215. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. 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. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. 2018;29(4):397406. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. 24. Dr. Shaffrey has received grants from the NIH and Department of Defense. JAMA Intern Med. 7. South Med J 62:17, 1969. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. 0 attorneys agreed. 27. 26. Per-patient analysis reveals more concerning numbers toward screw misplacement. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. 3. 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. The remaining eight patients, including two patients with spinal trauma, five patients with infection, and one patient with a tumor, had anterior and posterior procedures. Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. Continued clinical experience with various pedicle screw implant systems has led to ongoing improvements in system design to minimize implant failure rates and to improve ease of system application. 39. Spine 13:952953, 1988. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. 18. 11. Dr. Abd-El-Barr is a consultant for Spineology. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. 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. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. All Rights Reserved. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. 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. 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. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. 20. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). Nominal and inflation-adjusted award payouts were higher for trial verdicts than for settlement/arbitration, with a nominal average of $1,140,473 $841,683 versus $788,533 $306,186 awarded to the plaintiff, respectively (p = 0.30). McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Some error has occurred while processing your request. 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. Of note, the award amount for one settlement case was undisclosed. However, the highest offer had been a combined $300,000 from the two defendants. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. 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). 3. JAMA. Dr. Goodwin has received grants from the Burroughs Wellcome Fund, North Carolina Spine Society, and Robert Wood Johnson Harold Amos Medical Faculty Development Program and the NIH/NINDS K12 NRCDP Physician Scientist Award. 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. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. 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. Defensive medicine in U.S. spine neurosurgery. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. 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. The plaintiff underwent revision surgery in May 2013. 2020;162(6):13791387. Results: 13. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Before 2002;27(22):24252430. 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. The plaintiff will recover $2.25 million because of a high-low agreement the lawyers entered after closing arguments, the New Jersey Law Journal reports. St Louis, CV Mosby 322327, 1987. 34. All the incidental dural tears were repaired immediately and produced no clinical sequelae. 2. 21. A total of 2724 screws were placed in 127 patients. 2017;27(4):470475. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. A p < 0.05 was considered statistically significant. 16. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. Spine 19:25842589, 1994. This patient recovered completely in 6 weeks. Epub 2014 Apr 4. Under this theory of liability, the plaintiff needed to not only establish that she had experienced foot drop, a fact that no one was disputing, but that it was caused by the defendants negligence. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. 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. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. 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. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. 2014;21(3):320328. 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. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 2012;41(2):6973. Your message has been successfully sent to your colleague. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. The link was not copied. Spine (Phila Pa 1976). 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). Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt Under the high-low agreement, Drs. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. Epub 2022 Oct 29. Critically revising the article: all authors. 2011;306(10):1088. to maintaining your privacy and will not share your personal information without 2018;43(14):984990. National Library of Medicine The median time to case closure was longer for defendant-awarded cases, but this finding was not statistically significant (61.5 vs 56.3 months, p > 0.05). Hecht N, Kamphuis M, Czabanka M, et al. Neurosurgery. 31. General complications were considered those developing during and after surgery that were not directly related to instrumentation. Spine 18:11601172, 1993. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. 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. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. 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. Spine 8:970981, 1996. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 14. 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. 2. 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. Objective: This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. J Bone Joint Surg 45A:11591170, 1963. Segal J. 2013;34(6):699705. Lumbar Spine Surgery. 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. Patient safety: disclosure of medical errors and risk mitigation. Spine 13:10121018, 1988. 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. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. official website and that any information you provide is encrypted 2. 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. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. Clin Orthop 203:4553, 1986. 8,24,25,32. 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. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Clin Orthop 227:1023, 1988. 38. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. J Am Coll Surg. Spine 15:908912, 1990. 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. 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. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. 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. and 17.1% of the patients included had at least one screw misplaced. J Neurosurg Spine. An official website of the United States government. 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. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. 33. 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. Balch CM, Oreskovich MR, Dyrbye LN, et al. 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. 2007;106(6):11081114. 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. A retrospective review of charts, XRs and low-dose CT scans of 127 patients who underwent spinal fusion with pedicle screws for spinal deformity was performed. 4). Facebook Google Plus Youtube RSS Email. The medicolegal landscape of spine surgery: how do surgeons fare? Neurologic injury. Spine J. 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. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Spine Deform. MeSH Likewise, research shows that breaches still occur when these tools are used,33,40 and some studies did not find a difference in pedicle breach rates compared to those with traditional fluoroscopic and freehand techniques.33 Ultimately, misplaced instrumentation is a risk of any spinal fusion surgery, and a thorough discussion of these risks, as well as the alternative management options, is essential to maintain high-quality patient care and to avoid litigation. For more information, please refer to our Privacy Policy. 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. 2020;45(2):E111E119. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. Svider PF, Kovalerchik O, Mauro AC, et al. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. Acta Neurochir (Wien). Autor de la entrada Por ; Fecha de la entrada austin brown musician; matrix toners for bleached hair . 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. 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. 5. 15. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. Copyright © 2023 Becker's Healthcare. Personal consequences of malpractice lawsuits on American surgeons. Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. Can Postoperative Radiographs Accurately Identify Screw Misplacements? The medicolegal landscape of spine surgery: how do surgeons fare? Accessibility 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. Although pedicle screw fixation opened a new horizon of spinal surgery by providing rigid fixation of the spine, it is a technically demanding procedure with potential complications including medical complications, hardware and technical problems, and long-term changes of junctional motion segments.

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