The accuracy of pedicle screw placement using intraoperative image guidance systems. 27,30 Infected pseudarthrosis developed in one patient (0.9%) with an L4S1 arthrodesis, and the instrumentation was removed 18 months later resulting in a flat back syndrome. 36. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Acta Neurochir (Wien). In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. 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. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. Reviewed submitted version of manuscript: all authors. Pitfall: Unstable injuries. your express consent. What can spine surgeons do to improve patient care and avoid medical negligence suits? Luque ER: Segmental spinal instrumentation of lumbar spine. 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. 2007;106(6):11081114. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Am J Otolaryngol. 1. 24. Please try after some time. Sethi MK, Obremskey WT, Natividad H, et al. Clin Orthop 203:126134, 1986. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). 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. Please enable scripts and reload this page. Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. Although pedicle screw fixation opened a new horizon of spinal surgery by providing rigid fixation of the spine, it is a technically demanding procedure with potential complications including medical complications, hardware and technical problems, and long-term changes of junctional motion segments. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. 2014;20(2):196203. Spine 6:263267, 1981. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Din RS, Yan SC, Cote DJ, et al. (A) Anteroposterior and (B) lateral radiographs show coronal imbalance that developed 4 years after surgery in a 57-year-old woman with L3L4 float fusion. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Percentage of cases per US region (center). 8. The initial search using the terms above returned 3654 cases. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. Thu, May 27th, 2021. 8,24,25,32. 3. 2014;75(6):609613. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. J Spinal Disord Tech. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. The radiology results showed that the surgical screw placed at the right L4-5 area had breached the medial wall and was actually extending into the spinal canal. 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 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. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. government site. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. 5. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. 2013;123(9):20992103. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. 2002;27(22):24252430. Spine (Phila Pa 1976). In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. 2012;89(10):7071. Spine 6:615619, 1981. Your message has been successfully sent to your colleague. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. Am J Transl Res. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. St Louis, CV Mosby 322327, 1987. 13. demonstrated that the number of hospital discharges for spinal fusion increased 2.4 times (137%) from 174,223 to 413,171 (p < 0.001) between 1998 and 2008.32 The true frequency of malpositioned pedicle and lateral mass screws is likely underestimated in spine surgery given the fact that the majority of misplaced screws, as well as the potential complications related to them, are not reported in practice and may be clinically silent. Malpractice liability and defensive medicine: a national survey of neurosurgeons. Please try again soon. All the incidental dural tears were repaired immediately and produced no clinical sequelae. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. J Neurosurg Spine. 15. 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. shooting in valdosta leaves one dead 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). Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. 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. Int Orthop 20:3542, 1996. Additional survey data have shown that 50% of physicians exhibit at least a temporary loss of self-esteem after a malpractice claim, and at least 25% experience depression.22 As stated above, the average neurosurgeon spends 27.2% of his or her entire career in an open malpractice claim,10 and each case can take an average of 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 Likewise, neurosurgeons have a higher risk than practitioners in other specialties of being named in multiple malpractice suits given the particularly high-risk nature of the specialty.10 Even when found in favor of the defendant (surgeon), each case ultimately takes a substantial emotional and financial toll on the physician(s) involved. Administrative/technical/material support: Mehta, Wang, KD Than. 33. 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. 0 attorneys agreed. Kreisman Law Offices has been handling Illinois surgical error lawsuits for individuals and families for more than 35 years in and around Chicago, Cook County and surrounding areas, including Batavia, Bellwood, Deerfield, Evanston, Franklin Park, and Lansing. This patient recovered completely in 6 weeks. Wolters Kluwer Health GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). 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 ]. 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. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. An official website of the United States government. Smith TR, Hulou MM, Yan SC, et al. 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). The .gov means its official. Screw misplacement. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. 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. The defendants explanation provided an explanation for why Nyquists foot drop did not resolve after the misplaced screw was removed and shed doubt on the plaintiffs theory of liability. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. 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. 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. Rothberg MB, Class J, Bishop TF, et al. 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. 21. Of note, the award amount for one settlement case was undisclosed. pedicle screw misplacement malpractice. Call Us Now For a Free Consultation | Toll Free: 800.583.8002 | Local: 312.346.0045, Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants , Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation , Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in, $75 Million Jury Verdict in Failure to Timely Diagnose Stroke, $18 Million Jury Verdict in Late Diagnosis of Breast Cancer, $300,000 Settlement for Excessive Use of Radiation, Chicago Medical Malpractice Lawyer Kreisman Law Offices Home, Contact Illinois Personal Injury Attorney Kreisman Law Offices. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Federal government websites often end in .gov or .mil. 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). 1. Insuring spinal neurosurgery. 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. Of note, the award amount for one settlement case was undisclosed. A total of 2396 screws were placed accurately (87.96%). You may be trying to access this site from a secured browser on the server. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Drafting the article: Sankey. Per-patient analysis reveals more concerning numbers toward screw misplacement. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). $ = US$. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. were excluded from analysis. 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). 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 Despite this problem, the clinical result was excellent. 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). Back pain/spinal stenosis and neurogenic claudication/radiculopathy were the most frequently reported indications for the index surgery, accounting for 13 (19.1%) and 11 (16.2%) cases, respectively. 2. The average age of the patients was 47 years and the average followup was 35 months. 18. The plaintiff underwent revision surgery in May 2013. Statistical analysis: Sankey. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. PLoS One. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. Five patients had uneventful early postoperative course. 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. Jena AB, Seabury S, Lakdawalla D, Chandra A. 16. 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. Bydon M, Xu R, Amin AG, et al. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. 37. 2011;365(7):629636. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. However, the highest offer had been a combined $300,000 from the two defendants. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. 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. Spine 17:834837, 1992. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. 11. Rynecki ND, Coban D, Gantz O, et al. A retrospective review of charts, XRs and low-dose CT scans of 127 patients who underwent spinal fusion with pedicle screws for spinal deformity was performed. Spine 16:576579, 1991. 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. 29. 12. Each side was judged separately. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. Spine 16(8 Suppl):S455458, 1991. Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt Med Econ. Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. 2011;24(1):1519. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. 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. 30. Spinal fusion procedures are increasingly performed each year, with Deyo et al. 2017;31(3):287288. Defensive medicine in neurosurgery: the Canadian experience. 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. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Introduction. Methods: J Spine Surg. 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. 38. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. Elizabeth Hofheinz, M.P.H., M.Ed. Critically revising the article: all authors. J Neurosurg Spine. Clinical Orthopaedics and Related Research411:86-94, June 2003. 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These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. We serve the following localities: Cook County including Arlington Heights, Barrington, Berwyn Township, Chicago, Des Plaines, Glenview, Orland Park, Palos Park, Schaumburg, and Tinley Park; DuPage County including Downers Grove, Naperville, and Bolingbrook; Kane County including Aurora, Elgin and Geneva; Lake County including Waukegan; and Will County including Joliet. 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. However, the misplacement of pedicle screws can lead to disastrous complications. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. may email you for journal alerts and information, but is committed 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. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. Nayar G, Blizzard DJ, Wang TY, et al. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. Neurologic injury. HHS Vulnerability Disclosure, Help 2016;102(2):358362. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. 2014;21(3):320328. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. 2020;162(6):13791387. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. Results. The amount awarded was not significantly different across US regions (p = 0.9; Fig. A p < 0.05 was considered statistically significant. 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). 19. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. Author links open overlay panel Mohamad Bydon a b 1, Dimitrios Mathios a b 1, Mohamed Macki a b, Rafael De la Garza-Ramos a b, Nafi Aygun c, Daniel M. Sciubba a, Timothy F. Witham a, Ziya L. Gokaslan a b, Ali Bydon a b, Jean-Paul Wolinksy a. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. It argued that the foot drop was unavoidable and due to the surgeons need to manipulate the right L5 nerve root in order to remove Nyquists herniated disc during the spinal fusion surgery. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws.