pedicle screw misplacement malpractice

Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. 35. Defensive medicine in U.S. spine neurosurgery. Balch CM, Oreskovich MR, Dyrbye LN, et al. Makhni MC, Park PJ, Jimenez J, et al. Defendant-awarded cases by US region (right). [] The accuracy for free-hand screw placement technique varies from 69% to 94%. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. 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 When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. Acta Neurochir (Wien). Br J Neurosurg. 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. 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. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Spine J. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Neurosurgical practice liability: relative risk by procedure type. 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. Spine 17:834837, 1992. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. 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. 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). Guillain A, Moncany AH, Hamel O, et al. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. States were then grouped by US region and case year by 5-year intervals. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? 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. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. 1. 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). Nayar G, Blizzard DJ, Wang TY, et al. Steffee AD, Biscup RS, Sitkowski DJ: Segmental spine plates with pedicle screw fixation: A new internal fixation device for disorders of the lumbar and thoracolumbar spine. J Bone Joint Surg 73A:11791184, 1991. 2018;29(4):397406. The accuracy of pedicle screw placement using intraoperative image guidance systems. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Administrative/technical/material support: Mehta, Wang, KD Than. Results: A total of 2724 screws were placed in 127 patients. Personal consequences of malpractice lawsuits on American surgeons. In the current series, including general complications, only 48 patients (43%) had no notable complication and the remaining 64 patients (57%) had one or more complications. 2018;41(5):e615e620. In six of these patients with injuries at the thoracolumbar area (four patients with bent screws and two patients with broken screws), the loss of correction ranged from 3 to 4.5 without change of anatomic reduction (Fig 1). J Pediatr Orthop. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. * 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. Cookie Policy. Dr. Shaffrey has received grants from the NIH and Department of Defense. However, the highest offer had been a combined $300,000 from the two defendants. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. Agarwal N, Gupta R, Agarwal P, et al. 2002;27(22):24252430. West III JL, Bradford DS, Ogilvie JW: Results of spinal arthrodesis with pedicle screw-plate fixation. Legal liability in iatrogenic orbital injury. Spine 18:11601172, 1993. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. 2. We also investigated the effect of bone mineral density (BMD), diameter of pedicle screws, and the region of spine on the pullout strength of pedicle screws. 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 try again soon. 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The patient had subsequent coronal imbalance and degeneration of the upper disc. Clin Orthop 284:8090, 1992. 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. Rynecki ND, Coban D, Gantz O, et al. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. Acquisition of data: Sankey. Drs. 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. 2014;96(4):266270. Would you like email updates of new search results? All case demographics are summarized in Table 1. pedicle screw misplacement malpractice. 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. Don't jump in get legal help. Epstein NE. Malpractice litigation following spine surgery. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. Clin Orthop 115:130139, 1976. 8. Copyright 2023 Becker's Healthcare. 1. Review of neurosurgery medical professional liability claims in the United States. Please enable it to take advantage of the complete set of features! 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. 15. 2020;11:38. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. Linking and Reprinting Policy. Dr. Friedlander did not order a CT or MRI until January 2013, when the pedicle screw was found to be in the wrong location and a failed fusion was diagnosed, according to the suit. 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. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. The medicolegal landscape of spine surgery: how do surgeons fare? Spine 18:18621866, 1993. 2018;43(14):984990. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. 2011;365(7):629636. 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. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. 2016;102(2):358362. Analysis and interpretation of data: Sankey, TT Than. 10. Bookshelf Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). Svider PF, Kovalerchik O, Mauro AC, et al. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. 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. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. 2014;20(2):196203. 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. Please enable scripts and reload this page. Pedicle screw insertion in the thoracolumbar spine. MeSH A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. 11. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. 37. Fortunately, most of the complications were minor and transient. 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. Federal government websites often end in .gov or .mil. Malpractice risk according to physician specialty. Spine (Phila Pa 1976). Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Nottmeier EW, Seemer W, Young PM. 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. 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). Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. Clipboard, Search History, and several other advanced features are temporarily unavailable. Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. What can spine surgeons do to improve patient care and avoid medical negligence suits? Facebook Google Plus Youtube RSS Email. 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. 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. Despite this problem, the clinical result was excellent. Eur Spine J. A total of 69 patients (mean age, 67.416 . ObjectThe goal of this study was to determine the incidence of screw misplacement and complications in a group of 102 patients who underwent transpedicle screw fixation in the lumbosacral spine with conventional open technique and intraoperative. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. official website and that any information you provide is encrypted 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. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. Ann Thorac Surg. Spine (Phila Pa 1976). 24. Schatlo B, Molliqaj G, Cuvinciuc V, et al. 1). Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. 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.

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