pedicle screw misplacement malpractice

Seven hundred sixty-three screws were inserted in 138 patients. laterally placed screws and the azygous vein on the right (T5-T11). Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. It has a great developing technique that is used for fixation and fusion in spine surgery. Defensive medicine: a culprit in spiking healthcare costs. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. 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. The average age of the patients was 47 years and the average followup was 35 months. 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. Defensive medicine in neurosurgery: the Canadian experience. Insuring spinal neurosurgery. 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 Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. 26. Mason A, Paulsen R, Babuska JM, et al. Bookshelf Spine (Phila Pa 1976). However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. pedicle screw misplacement malpractice. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. Results: 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. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. 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 Neurosurg Spine. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. 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. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. Facebook Google Plus Youtube RSS Email. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. A rod is used to hold the vertebra together to allow fusion to occur. Methods. Malpractice claims in spine surgery in Germany: a 5-year analysis. 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. J Am Coll Surg. 7. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Scarone P, Vincenzo G, Distefano D, et al. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. Hecht N, Kamphuis M, Czabanka M, et al. 2021 Jul 1;41(Suppl 1):S80-S86. Please try again soon. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal 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. Characteristics of medicolegal cases related to misplaced screws in spine surgery. Two patients with associated injuries in the lower limbs had deep venous thrombosis develop, three patients had pneumonia develop, and four patients with neurologic impairment had urinary tract infections develop. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. Of note, the award amount for one settlement case was undisclosed. Spine 13:10121018, 1988. The authors of the current study aimed to describe this impact in the United States, as well as to suggest a potential method for mitigating the problem. Spine 17:349355, 1992. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Dr. Abd-El-Barr is a consultant for Spineology. 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. 2005;293(21):26092617. Wolters Kluwer Health Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. NCI CPTC Antibody Characterization Program. 2006;65(4):416421. A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Am J Otolaryngol. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. Spine 16(8 Suppl):S422427, 1991. Can Postoperative Radiographs Accurately Identify Screw Misplacements? Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. 2013;32(1):111119. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. Introduction. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. 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. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. 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. (%), Pseudarthrosis requiring revision surgery. The rate of medical complications was 8%. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Int Orthop 20:3542, 1996. 2012;37(1):6776. Medical malpractice litigation has made a significant impact on spine surgery, with many spine surgeons avoiding complex cases or practicing other defensive medicine tactics in an effort to avoid being sued.5 Moreover, the majority of neurosurgeons spend more than 10% of their annual revenue on malpractice insurance,1,14 and the excessive financial risk of litigation is even leading some insurers to no longer offer coverage to spine surgeons.19 A 2011 study in the New England Journal of Medicine found that 19.1% of neurosurgeons are named as a defendant in a malpractice suit each year (highest of any specialty).12 Moreover, 88% of physicians in high-risk specialties, like neurosurgery, are involved in a lawsuit by age 45, increasing to a concerning 99% by 65 years of age.12 Such litigation places a substantial financial, temporal, and emotional burden on physicians in high-risk specialties, with studies showing that up to 72% of neurosurgeons1 admitted that their fear of litigation significantly influenced their practice,25 with many avoiding high-risk patients altogether.1 Similarly, Nahed et al. 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. Drs. 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. Privacy Policy. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. Conclusion: Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. Many technological advances have been made over the past several decades in an effort to improve the accuracy of screw placement in spine surgery.3436 For example, 3D fluoroscopybased image guidance has been shown to decrease the pedicle breach rate in several studies compared to the rate with 2D fluoroscopic guidance or the freehand technique, particularly in deformity and revision surgeries.21,34,36,37 CT guidance or intraoperative confirmation has also been shown to further improve the accuracy of pedicle screw placement,3638 with reported accuracy rates of 89%100% reported in the literature, depending on the authors breach criteria.35 However, it is important to note that the use of this technology is often accompanied by a lower threshold for intraoperative screw revision, sometimes leading to higher rates of replaced screws.33 Arguably, these improved trajectories may avoid iatrogenic neurological deficits due to prolonged nerve root compression or even improve the stability of the construct;34,37 however, prospective studies of long-term outcomes and rates of revision surgery remain sparse in the literature. may email you for journal alerts and information, but is committed Dr. Goodwin has received grants from the Burroughs Wellcome Fund, North Carolina Spine Society, and Robert Wood Johnson Harold Amos Medical Faculty Development Program and the NIH/NINDS K12 NRCDP Physician Scientist Award. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. Although the rationale for using pedicle screw fixation is fairly clear, controversy continues regarding the application of pedicle instrumentation for spine arthrodesis, especially on the degenerative lumbar spine. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. 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. Segal J. Epub 2021 Aug 28. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. 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. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Forty-seven general complications were seen in 41 patients (36.5%). A total of 69 patients (mean age, 67.416 . Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. National Library of Medicine McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. Clin Orthop 203:126134, 1986. The https:// ensures that you are connecting to the However, the highest offer had been a combined $300,000 from the two defendants. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. 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. 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. 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. 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. J Neurosurg. Routine CT scans were taken in all patients. They both had motor deficits from which 1 patient recovered completely. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. Friedlander and Bradley will pay half of the $2.25 million. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Spine 18:11601172, 1993. All Rights Reserved. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Spine 8:970981, 1996. Please enable it to take advantage of the complete set of features! Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. Health Aff (Millwood). Preparation. Sethi MK, Obremskey WT, Natividad H, et al. What can spine surgeons do to improve patient care and avoid medical negligence suits? 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. 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. 2007;106(6):11081114. 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). A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. 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. 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. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. 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. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Of note, while only 38.2% (n = 26) of cases in our study mentioned the use of intraoperative radiographic confirmation, only one of these cases reported that the misplaced screw had been caught prior to leaving the operating room, which had resulted in an inadvertent dural tear and L5 nerve root injury. Taylor CL. 6. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. Instead, the defense offered up an alternative explanation for Nyquists foot drop. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. Critically revising the article: all authors. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. 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. The average followup was 35 months (range, 1851 months). Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. 36. Moffatt-Bruce SD, Ferdinand FD, Fann JI. You may be trying to access this site from a secured browser on the server. Methods: 2012 Feb 1;37(3):E188-94. However, only a few complications were related to a poor clinical outcome. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. Epstein NE. 0 attorneys agreed. However, this difference was no longer significant when adjusted for inflation ($1,016,000 $90,875 vs $1,630,000 $422,405, p = 0.09). 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. Agarwal N, Gupta R, Agarwal P, et al. 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. 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. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. 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. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. Eur Spine J. All the incidental dural tears were repaired immediately and produced no clinical sequelae. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. The accuracy of pedicle screw placement using intraoperative image guidance systems. 2. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. 19. 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). General complications were considered those developing during and after surgery that were not directly related to instrumentation. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. 2011;24(1):1519. 2012;89(10):7071. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. 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. and transmitted securely. A total of 2724 screws were placed in 127 patients. Todd NV. Analysis and interpretation of data: Sankey, TT Than. 144 In addition, hardware failures were observed in 12 patients (10.7%), junctional problems were seen in five patients (4.5%), problems in the instrumented segments were seen in 39 patients (34.7%), and problems of balance occurred in five patients (4.5%). After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. 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. In the current study, only five patients with junction problems above the instrumented area were observed with the following probable predisposing factors: an already degenerative disc, coronal imbalance, very long arthrodesis, and old age. $ = US$. 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. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . Epub 2022 Oct 29. Rothberg MB, Class J, Bishop TF, et al. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. J Neurosurg Spine. sharing sensitive information, make sure youre on a federal 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 West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. Clin Orthop 203:4553, 1986.

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