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Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. Epub 2022 Oct 29. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. However, only a few complications were related to a poor clinical outcome. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. 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. Defensive medicine in neurosurgery: the Canadian experience. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. 9. Clin Orthop 284:8090, 1992. 10. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. Eur Spine J. Pedicle screw placement is a common procedure. Spine 14:472476, 1989. 2016;102(2):358362. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Personal consequences of malpractice lawsuits on American surgeons. Under the high-low agreement, Drs. Harrington and Tullos 11 first reported the technique of transpedicle screw fixation, and Roy-Camille et al 23 popularized the first practical method of pedicle screw fixation. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. Several limitations should be carefully considered when interpreting our results. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. 19. Pitfall: Unstable injuries. What can spine surgeons do to improve patient care and avoid medical negligence suits? 16. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). Your current browser may not support copying via this button. A rod is used to hold the vertebra together to allow fusion to occur. 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). Neurological outcome and management of pedicle screws - PubMed Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. Epub 2014 Jun 13. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? Orthop Trans 11:99, 1987. Spine 17:349355, 1992. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). Malpractice liability and defensive medicine: a national survey of neurosurgeons. 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. Spine (Phila Pa 1976). 30. Review of neurosurgery medical professional liability claims in the United States. 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. 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. Preparation. Spine 19:25842589, 1994. A total of 2396 screws were placed accurately (87.96%). Ahmadi SA, Sadat H, Scheufler KM, et al. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. The median time to case closure was 56.3 (35.267.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.477.2) months for defendant (surgeon) verdicts (p = 0.117). Spine Deform. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. The plaintiff received $2.4 million for pain and suffering and loss of enjoyment of life, $2 million for lost income and approximately $123,000 for medical expenses. 4). Bydon M, Xu R, Amin AG, et al. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. A total of 69 patients (mean age, 67.416 . General complications were considered those developing during and after surgery that were not directly related to instrumentation. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. Spine 24:23522357, 1999. Clin Orthop 203:4553, 1986. 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. Statistical analysis: Sankey. Malpractice litigation following spine surgery. 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. Careers. 32. 2009;10(1):3339. Dr. Shaffrey has received grants from the NIH and Department of Defense. Epstein NE. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. Li HM, Zhang RJ, Shen CL. 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. Spine 6:615619, 1981. Mason A, Paulsen R, Babuska JM, et al. Mississippi Appellate Court Affirms Medical Malpractice Defense Verdict Pedicle screw placement accuracy using ultra-low radiation imaging with image enhancement versus conventional fluoroscopy in minimally invasive transforaminal lumbar interbody fusion: an internally randomized controlled trial. 36. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. J Neurosurg Spine. 15. Yuan et al 37 reported that the use of spinal instrumentation is associated with higher rate of infection (3%6%), neurologic injury (1%5%), instrumentation failure (6%10%), and reoperation (20%), compared with in situ arthrodeses. Pedicle Screw Malposition Expert Witness: Malposition Can Lead to 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. J Neurosurg Spine. The third patient, who had central spinal stenosis, was treated by decompression alone. Before Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. Epub 2021 Aug 28. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. pedicle screw misplacement malpractice 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. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. 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. J Neurosurg 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. Nahed BV, Babu MA, Smith TR, Heary RF. Nevertheless, research has shown that screws are misplaced in approximately 14%55% of cases using the standard techniques (freehand and 2D fluoroscopic guidance) employed by most spine surgeons,21,33 resulting in injury in approximately 1%8% of cases.21 In addition to the avoidable procedural risk to the patient, each misplaced screw carries the threat of future litigation, as reported above. 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. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults, Spinal fusion in the United States: analysis of trends from 1998 to 2008, Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws, The accuracy of pedicle screw placement using intraoperative image guidance systems, 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, Pedicle screw placement accuracy using ultra-low radiation imaging with image enhancement versus conventional fluoroscopy in minimally invasive transforaminal lumbar interbody fusion: an internally randomized controlled trial, 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, Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO, 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, Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison, Verdict/Settlement Search and Inclusion/Exclusion Criteria, Plaintiff Claim and Index Surgery Information, Impact of Medical Malpractice on Neurosurgeon and Orthopedic Surgeon Careers, Financial Burden of Medical Malpractice Claims Related to Misplaced Pedicle and/or Lateral Mass Screws, Frequency of Misplaced Pedicle and Lateral Mass Screws in Spine Surgery, Strategies to Improve the Accuracy of Screw Placement in Spine Surgery, Top 25 Cited Gamma Knife Surgery Articles - Trigeminal Neuralgia, Top 25 Cited Gamma Knife Surgery Articles - Volume 111, https://doi.org/10.3171/2020.8.FOCUS20600, https://www.bls.gov/data/inflation_calculator.htm, Volume 49 (2020): Issue 5 (Nov 2020): Medicolegal issues in neurosurgery, Single vs multiple misplaced screw(s), no. 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. JAMA. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. Rothberg MB, Class J, Bishop TF, et al. 12. Spine (Phila Pa 1976). pedicle screw misplacement malpractice. J Bone Joint Surg 45A:11591170, 1963. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. Ann R Coll Surg Engl. Studdert DM, Mello MM, Sage WM, et al. Am J Orthop. Pedicle screw replacement in spinal surgery - The MDU Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. 26. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. What can spine surgeons do to improve patient care and avoid medical negligence suits? Characteristics of medicolegal cases related to misplaced screws in spine surgery. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) Pullout strength of misplaced pedicle screws in the thoracic and lumbar 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. Taylor CL. 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. The medicolegal landscape of spine surgery: how do surgeons fare? 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. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 2017;42(3):177185. HHS Vulnerability Disclosure, Help SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. Lali Sekhon, Jocelyn Idema & more: 4 spine and neurosurgeons making headlines, Spinal cord stimulation trumps medication for pain reduction 7 takeaways, Dr. Khalid Kurtom on major trends in spinal cord injury surgery. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com.