pedicle screw misplacement malpractice11 Mar pedicle screw misplacement malpractice
Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Nottmeier EW, Seemer W, Young PM. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. 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. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. 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. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. Materials and Methods Sixty . Neurosurgical practice liability: relative risk by procedure type. Spine 6:615619, 1981. 6. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. Malpractice issues in neurological surgery. Clin Orthop 203:717, 1986. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. For more information, please refer to our Privacy Policy. Spine 13:952953, 1988. leg pain. 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. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. Before A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. 2006;65(4):416421. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. 4. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. This site needs JavaScript to work properly. Health Aff (Millwood). 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. 2014;75(6):609613. Clin Orthop 203:126134, 1986. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. Luque ER: Segmental spinal instrumentation of lumbar spine. Each side was judged separately. 18. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Copyright 2023 Becker's Healthcare. 2012;21(suppl 2):S196S199. 5 Those authors recommend that particular care should be taken in inserting the washers without cross threading and ensuring that they are locked down tightly, with an adequate length of rod protruding beyond the screw. You are talking one of the most complicated area of the law. Rovit RL, Simon AS, Drew J, et al. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. Over 40% of patients had screws with either some/major concern. 2017;31(3):287288. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. 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. 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. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Nationally Recognized Regionally Dominant Contact Us Now For a Free Consultation Over $850 Million in Verdicts and Settlements Home Articles Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Spine 16(8 Suppl):S422427, 1991. N Engl J Med. 25. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. They both had motor deficits from which 1 patient recovered completely. Bookshelf Acta Neurochir (Wien). Jena AB, Seabury S, Lakdawalla D, Chandra A. Neurosurgery. Spine (Phila Pa 1976). The medical malpractice suit Ayala v. Friedlander, M.D., claimed that a March 2011 lumbar fusion surgery performed by neurosurgeon Marvin Friedlander, MD, and orthopedic spine surgeon Douglas Bradley, MD, strayed from the accepted standards of care because a pedicle screw was placed in the wrong location. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. Operative information including fusion level, number of levels fused, level of misplaced screw(s), single versus multiple misplaced screw(s), presence of known CSF leakage, and primary injury due to screw misplacement was also collected. Hecht N, Kamphuis M, Czabanka M, et al. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). 2009;10(1):3339. 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. 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). Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. 2. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. Clin Orthop 227:1023, 1988. To prevent general complications, it is evident that precise and careful soft tissue handling, proper irrigation, and debridement during and after surgery, decrease of operative time, and proper patient monitoring postoperatively must be done. 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 Show more. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. However, only a few complications were related to a poor clinical outcome. 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. Potential complications may include increased pain, infection, or mechanical . In the Kane County medical malpractice lawsuit of Melissa Nyquist v. Dr. Taras Masnyk and DuPage Neurosurgery, S.C., 06 L 421, the plaintiffs attorney was unable to convince the jury that the plaintiffs medical complications were caused by the defendants negligence. 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). L3S1 spine arthrodesis was done in the first patient but the correction of scoliosis was not sufficient and coronal imbalance persisted after surgery, which accelerated the degeneration of the level just above the arthrodesis. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. 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. 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. All case demographics are summarized in Table 1. 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. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. Spine 16:576579, 1991. 2018;41(5):e615e620. The https:// ensures that you are connecting to the 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. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. The suit claimed Dr. Friedlander failed to diagnose and treat the mispositioned screw in a timely manner, leading the plaintiff to develop pain in his right leg, numbness in his right calf and weakness in his right toes. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). Malpractice risk according to physician specialty. The amount awarded was not significantly different across US regions (p = 0.9; Fig. 2014;96(4):266270. 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. Can Postoperative Radiographs Accurately Identify Screw Misplacements? 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. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Cerebrospinal fluid fistulas. Hardware problems were those related to the physical change of metal and screw position. 24. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. 20th Annual Spine, Orthopedic & Pain Management-Driven ASC Conference, 8th Annual Health IT + Digital Health + RCM Conference, 29th Annual Meeting - The Business & Operations of ASCs, The issues spine surgeons are advocating for outside of the operating room, Centinel Spine is now covered by all major payers, What's next for SI joint fusion? doi: 10.1097/BPO.0000000000001828. The screws were needed to stabilize the spine and fix the fused vertebrae in place. government site. Spine 19(20 Suppl):2279S2296, 1994. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. Scarone P, Vincenzo G, Distefano D, et al. 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. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Orthop Trans 11:99, 1987. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. Clin Orthop 203:4553, 1986. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. 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. Dr. Abd-El-Barr is a consultant for Spineology. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). Plaintiff-awarded cases by US region (left). 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). However, the misplacement of pedicle screws can lead to disastrous complications. Surg Neurol. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . 2005;293(21):26092617. Epstein NE. 10. 2014;20(6):636643. Presse Med 78:14471448, 1970. The most frequent primary injury listed for a lawsuit was nerve root injury, present in 81.0% (n = 17) and 74.5% (n = 35) of plaintiff- and defendant-awarded cases, respectively (p = 0.7). Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. 31. Svider PF, Husain Q, Kovalerchik O, et al. 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. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. You may be trying to access this site from a secured browser on the server. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. * Taylor CL. In several of the studies in the spinal literature, the contention that instrumentation improves arthrodesis rates, considering that nonunion contributes to a poor outcome in spinal arthrodesis is favored. And while the offending screw was removed the next day, Nyquist continued to experience right foot drop, along with lower back pain and sciatica, i.e. 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. Preparation. Ahmadi SA, Sadat H, Scheufler KM, et al. Linking and Reprinting Policy. Elizabeth Hofheinz, M.P.H., M.Ed. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. Spine 18:11601172, 1993. 26 They support that after a lengthy symptom-free period, segments next to a fused segment can break down and the segment next to the adjacent segment is almost as likely to break down as the adjacent segment. Reviewed submitted version of manuscript: all authors. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Sethi MK, Obremskey WT, Natividad H, et al. Clin Orthop 284:8090, 1992. 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. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. 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. Median screw misplacement rate was 10% in group A and 13% in group B. Clinical Orthopaedics and Related Research411:86-94, June 2003. 13. 2014;174(11):18671868. Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. This patient recovered completely in 6 weeks. A.J. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. A total of 2396 screws were placed accurately (87.96%). Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. 2011;365(7):629636. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. 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. Call me tomorrow. Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 14. 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 Intraoperative pedicle fractures requiring further points of fixation. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. 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. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. Both issues represent the most frequent and highest payouts in spine malpractice claims.10,14,22 While several studies have explored many of the factors related to malpractice claims in spine surgery, the medicolegal impact of misplaced pedicle and/or lateral mass screws has not been directly reported in the literature. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. Spine 18:23252326, 1993. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. 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). Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. Am J Transl Res. Din RS, Yan SC, Cote DJ, et al. The site is secure. Epub 2022 Oct 29. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . 2018;83(5):9971006. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. Int Orthop 20:3542, 1996. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine.
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