pedicle screw misplacement malpractice

pedicle screw misplacement malpractice

Spine 18:11601172, 1993. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. 2022 Sep 15;14(9):6323-6331. eCollection 2022. 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. 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 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. . Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Moffatt-Bruce SD, Ferdinand FD, Fann JI. One hundred twelve patients were treated using the Cotrel-Dubousset pedicle screw fixation system for degenerative disease (57 patients), trauma (42 patients), infection (eight patients), and tumor (five patients) of the lumbar or thoracolumbar spine. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. doi: 10.1097/BPO.0000000000001828. Call me tomorrow. 2017;27(4):470475. J Bone Joint Surg 45A:11591170, 1963. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. were excluded from analysis. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. 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. 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. Malpractice litigation following spine surgery. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. 2012;21(suppl 2):S196S199. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Ultimately, additional prospective, multiinstitutional large-volume studies are needed to validate these findings, and future studies should evaluate the long-term impact on the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation on the frequency and success of malpractice claims related to misplaced pedicle and lateral mass screws. The initial search using the terms above returned 3654 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). Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. (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. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Li HM, Zhang RJ, Shen CL. 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. + 48 696 042 504. However, the misplacement of pedicle screws can lead to disastrous complications. 25. The accuracy of pedicle screw placement using intraoperative image guidance systems. 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. Malpractice issues in neurological surgery. 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. Spine J. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). 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. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. Todd NV. Two-dimensional (2D) fluoroscopy-guided percutaneous pedicle screw (PPS) placement is currently the most widely applied instrumentation for minimally invasive treatment of spinal injuries requiring stabilization. 14. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . In White AH, Rothman RH, Ray CD (eds). Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. J Neurosurg Spine. 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. Under the high-low agreement, Drs. shooting in valdosta leaves one dead 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. 2016;102(2):358362. Conception and design: Sankey, KD Than. 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. For more information, please refer to our Privacy Policy. Epub 2021 Aug 28. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). Linking and Reprinting Policy. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. 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 standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. 1). Studies have shown that the greatest proportion of malpractice claims in spine surgery are related to procedural error,10,11,14,16,17,19 often resulting in the highest payouts.11,20 For spine surgery, one common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass screws, which occurs in approximately 14%55% of cases using standard techniques and results in neurological injury and/or durotomy in approximately 1%8% of cases.21 Misplaced screws have the potential to cause severe and sometimes permanent neurological deficits, including spinal cord and/or nerve root injury,21 as well as to decrease the stability of the fusion construct, leading to delayed complications related to pseudarthrosis. 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. 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. Objective: 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. Schatlo B, Molliqaj G, Cuvinciuc V, et al. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. 2011;306(10):1088. 37. You are talking one of the most complicated area of the law. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. Administrative/technical/material support: Mehta, Wang, KD Than. 19. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. This study has shown that percutaneous insertion of pedicle screws in the lumbar spine is a safe and reliable technique, and despite the low misplacement rate of only 6.6%, it should be kept in mind that the surgical procedure is technically demanding and should be performed only by experienced spine surgeons. Intraoperative pedicle fractures requiring further points of fixation. 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. 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. Defendant-awarded cases by US region (right). HHS Vulnerability Disclosure, Help Please try after some time. 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. Spine 13:10121018, 1988. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). 2 One of the first obstacles regarding . 2018;83(5):9971006. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. 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. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. 2018;41(5):e615e620. 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. 26. 4). Eur Spine J. 2. Arthrodesis was questionable in eight asymptomatic patients (7.1%). 3). Spine 24:23522357, 1999. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. 2011;365(7):629636. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. The average followup was 35 months (range, 1851 months). Laryngoscope. 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. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. I won't be at the office but I will check my voice mail. 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). 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. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). Spine (Phila Pa 1976). Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. 2011;213(5):657667. South Med J 62:17, 1969. sharing sensitive information, make sure youre on a federal 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. Spine 16(8 Suppl):S422427, 1991. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. 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. 12. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. Eur Spine J. 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. 2018;28(2):186193. 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. 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. Five patients had uneventful early postoperative course. 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). Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. Daniels AH, Ruttiman R, Eltorai AEM, et al. 10. (%), Pseudarthrosis requiring revision surgery. 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. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. Statistical analysis: Sankey. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. 2005;293(21):26092617. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. 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. West III JL, Bradford DS, Ogilvie JW: Results of spinal arthrodesis with pedicle screw-plate fixation. J Neurosurg. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. 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). The patient had to undergo a subsequent surgery to remove the pedicles. Spine (Phila Pa 1976). JAMA Intern Med. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. St Louis, CV Mosby 322327, 1987. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. 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. Several studies reveal that fusion rates increase when rigid internal fixation is used, 14,20,21,33,38 and that by using pedicle screws and plates or rods for stabilization, spinal arthrodesis can be limited to the disease segments. 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. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. The average age of the patients was 47 years and the average followup was 35 months. Please enable scripts and reload this page. 2012;37(1):6776. 2006;65(4):416421. 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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