pedicle screw misplacement malpractice

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). 14. Malpractice claims in spine surgery in Germany: a 5-year analysis. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. Accessibility Makhni MC, Park PJ, Jimenez J, et al. $ = US$. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. Please enable scripts and reload this page. 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. Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. Friedlander and Bradley will pay half of the $2.25 million. 2018;28(2):186193. Moffatt-Bruce SD, Ferdinand FD, Fann JI. 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). 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. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. West et al 33 also reported a 29% complication rate for the first 50 patients and a 26% complication rate for the last 74 patients. Spine 13:952953, 1988. Five patients had uneventful early postoperative course. Orthop Trans 11:99, 1987. Copyright © 2023 Becker's Healthcare. There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). N Engl J Med. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. Defensive medicine in neurosurgery: the Canadian experience. 33. Unable to load your collection due to an error, Unable to load your delegates due to an error. 2017;27(4):470475. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Pitfall: Unstable injuries. leg pain. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. Orthopedics. 12. Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. 6 Copyright 2023 Becker's Healthcare. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? 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. Spine 18:983991, 1993. 2006;65(4):416421. Weinstein JN, Spratt KF, Spengler D, Brick C, Reid S: Spinal pedicle fixation: Reliability and validity of roentgenogram-based assessment and surgical factors on successful screw placement. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. Each side was judged separately. 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). 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. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). JAMA. NCI CPTC Antibody Characterization Program. Facebook Google Plus Youtube RSS Email. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. The contact form sends information by non-encrypted email, which is not secure. Deyo RA, Mirza SK, Martin BI. 0 attorneys agreed. In White AH, Rothman RH, Ray CD (eds). Pedicle screw insertion in the thoracolumbar spine. Bookshelf Spine 16(8 Suppl):S422427, 1991. Dr. Abd-El-Barr is a consultant for Spineology. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. 2014;75(6):609613. Hardware problems were those related to the physical change of metal and screw position. 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. 13. 2 One of the first obstacles regarding . Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. However, the highest offer had been a combined $300,000 from the two defendants. Quraishi NA, Hammett TC, Todd DB, et al. * 24. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. 10. Epub 2014 Jun 13. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. J Neurosurg. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. 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 Laryngoscope. Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . 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. 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. Conception and design: Sankey, KD Than. Spine (Phila Pa 1976). 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. The medicolegal landscape of spine surgery: how do surgeons fare? Din RS, Yan SC, Cote DJ, et al. Mason A, Paulsen R, Babuska JM, et al. 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. This patient recovered completely in 6 weeks. 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). laterally placed screws and the azygous vein on the right (T5-T11). Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. I won't be at the office but I will check my voice mail. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. All case demographics are summarized in Table 1. This device was used with an early version of the Cotrel-Dubousset instrumentation to provide sacral fixation and it is rarely used since the more widespread use of newer spine fixation systems. J Neurosurg. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. 2020;11:38. Several limitations should be carefully considered when interpreting our results. Spine 15:908912, 1990. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. 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 ]. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. In their meta-analysis of nine randomized controlled trials, Li et al. To investigate intraoperative reinsertion of percutaneous pedicle screw (PPS) with intraoperative CT-based navigation and to evaluate the rate of deviation of PPS at postoperative radiographic examination. JAMA. 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). 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. 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. 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. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. Guillain A, Moncany AH, Hamel O, et al. Scarone P, Vincenzo G, Distefano D, et al. Am J Otolaryngol. 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. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. 5. You are talking one of the most complicated area of the law. 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. Neurosurgical practice liability: relative risk by procedure type. The patient had subsequent coronal imbalance and degeneration of the upper disc. To prevent the development of pseudarthrosis, we think it is important for surgeons to apply the following five technical principles: the proper-sized pedicle screw has to be inserted on the first attempt; repeated manipulation in setting instruments must be avoided; anterior penetration of the screw into the sacrum and insertion of two screws in each side are advocated for fixing the lumbosacral junction; industrious and detailed decortication of the posterior elements must be developed fully; and the use of autologous bone graft is recommended. 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. . Cookie Policy. 2019;19(7):12211231. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. Am J Transl Res. Objective: Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. Nyquist followed a medical malpractice lawsuit against Dr. Masnyk for his surgical error, alleging that the surgeon had improperly positioned the right L4 pedicel screw which had resulted in a nerve root injury and Nyquists subsequent foot drop. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. pedicle screw misplacement malpractice. Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. 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. The .gov means its official. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. Malpractice liability and defensive medicine: a national survey of neurosurgeons. 2018;29(4):397406. 18. Despite this problem, the clinical result was excellent. Materials and Methods Sixty . The plaintiff underwent revision surgery in May 2013. A total of 2724 screws were placed in 127 patients. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. Reviewed submitted version of manuscript: all authors. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. Similarly, the highest inflation-adjusted amount awarded ($2,302,472) for pseudarthrosis was attributed to a medially breached pedicle screw during an L5S1 fusion that was determined to have caused the failed union and subsequent need for revision surgery. Accuracy of pedicle screw placement and clinical outcomes of robot-assisted technique versus conventional freehand technique in spine surgery from nine randomized controlled trials: a meta-analysis. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. 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. Furthermore, 25 patients (22.3%) reported persistent pain in the iliac crest (donor graft site) for several months, for which they were treated with repeated lidocaine injections and analgesics. Spine (Phila Pa 1976). Characteristics of medicolegal cases related to misplaced screws in spine surgery. The patient had to undergo a subsequent surgery to remove the pedicles. Nahed BV, Babu MA, Smith TR, Heary RF. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. This site needs JavaScript to work properly. 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. 4. 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. 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). Unauthorized use of these marks is strictly prohibited. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. Can Postoperative Radiographs Accurately Identify Screw Misplacements? The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). Spine 24:23522357, 1999. However, the misplacement of pedicle screws can lead to disastrous complications. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. 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 Data is temporarily unavailable. Eur Spine J. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). 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. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. 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. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. All Rights Reserved. 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. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Med Econ. 34. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. 19. The average age of the patients was 47 years and the average followup was 35 months. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Fortunately, most of the complications were minor and transient. 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. Wolters Kluwer Health All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. 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. One hundred four of the 112 patients had a posterior procedure. Defendant-awarded cases by US region (right). J Bone Joint Surg 73A:11791184, 1991. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. 2013;32(1):111119. The physician ordered an MRI of the lumbar spine which showed that the screws had been misplaced and were puncturing the patient's lumbar nerves. Agarwal N, Gupta R, Agarwal P, et al. Dr. Shaffrey has received grants from the NIH and Department of Defense. 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. 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. 2012 Feb 1;37(3):E188-94. Privacy Policy. Svider PF, Kovalerchik O, Mauro AC, et al. 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. Neurologic injury. 144 Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. Show more. Clin Orthop 203:717, 1986. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Neurosurgery. St Louis, CV Mosby 322327, 1987. 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. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. Spine 17:834837, 1992. J Bone Joint Surg 61A:201207, 1979. 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. 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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