Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. 19. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. 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. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. Conclusion: To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. J Bone Joint Surg 54A:11951204, 1972. J Spinal Disord Tech. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. 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. 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. Of note, the award amount for one settlement case was undisclosed. Pedicle screw placement is a common procedure. 2005;293(21):26092617. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. Bethesda, MD 20894, Web Policies South Med J 62:17, 1969. Health Aff (Millwood). 8,24,25,32. 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. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. Pedicle screw fixation is commonly used in spinal instrumentation surgeries to connect rods to vertebrae in order to correct spine alignment, stabilize vertebrae, and reach an arthrodesis. J Neurosurg Spine. Show more. 7. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. All the incidental dural tears were repaired immediately and produced no clinical sequelae. Spine (Phila Pa 1976). Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine.
Pedicle screw accuracy in thoracolumbar fractures- is routine Spine 15:1114, 1990. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. The medicolegal landscape of spine surgery: how do surgeons fare? Malpractice issues in neurological surgery. Re: malpositioned pedicle screw resulting in additional surgery and disability.
Pedicle Screw Malposition Expert Witness: Malposition Can Lead to Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants Irwin v. Alan Loren, M.D. For more information, please refer to our Privacy Policy.
Jury Verdict for Doctor for Screw Allegedly Misplaced During Lumbar Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. 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. There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). Before Ann R Coll Surg Engl. Surg Neurol Int. 22. 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. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. The intent is to provide relief from pain and nerve damage. Spine 14:472476, 1989. Reviewed submitted version of manuscript: all authors. 3. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. 36. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley.
$2 Million Spinal Surgery Case Against Neurosurgeon and Hospital 2016;25(3):716723. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). 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. 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. 5. J Neurosurg Spine. HHS Vulnerability Disclosure, Help Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. Clipboard, Search History, and several other advanced features are temporarily unavailable. 18. Spine Deform. Copyright 2023 Becker's Healthcare. 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. Fortunately, most of the complications were minor and transient. Five patients had uneventful early postoperative course. While the majority of claims are found to lack merit, resulting in a verdict in favor of the defendant or case dismissal,7,1316 at least 37% are considered valid.26 Regardless, payouts to plaintiffs are often substantial, averaging in the hundreds of thousands to millions of dollars in both the US and Europe.10,11,14,17,20 Communication of errors and expectations, thorough documentation, and selection of appropriate patients and surgical indications have been shown to reduce the likelihood of a successful malpractice claim.13,16,27,28 In addition, attempts at tort reform in some states have helped limit the financial burden of medical malpractice payouts through methods such as capitation.16,20,22,26 However, efforts to limit malpractice claims in the first place are greatly needed. 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. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Spine 8:970981, 1996.
Neurological outcome and management of pedicle screws - PubMed The incidence of screw failure, which can occur despite solid arthrodesis, 7 in the current series was 8% and mainly involved patients with thoracolumbar injury. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR.
The medicolegal impact of misplaced pedicle and lateral mass screws on leg pain. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. . Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. None of these complications resulted in additional surgery or in a significant increase of morbidity. Presse Med 78:14471448, 1970.
Reoperation for Misplaced Pedicle Screws: A Multicenter Retrospec A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. The patient had subsequent coronal imbalance and degeneration of the upper disc. 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. The literature gave a range of screw misplacement rates detected on postoperative imaging of between 1% and 18%, with the rate generally considered to be around 10%. Guillain A, Moncany AH, Hamel O, et al. 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. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. Clinical Orthopaedics and Related Research, Get new journal Tables of Contents sent right to your email inbox, The Association of Bone and Joint Surgeons, Complications and Problems Related to Pedicle Screw Fixation of the Spine, Articles in Google Scholar by Pavlos Katonis, MD, Other articles in this journal by Pavlos Katonis, MD, Privacy Policy (Updated December 15, 2022). Please enable it to take advantage of the complete set of features! 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. 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. 8600 Rockville Pike The site is secure. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. You are talking one of the most complicated area of the law. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. Accessibility J Neurosurg Spine. 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). Results: A total of 2724 screws were placed in 127 patients. Of note, the award amount for one settlement case was undisclosed. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. 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. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. Med Econ. Nottmeier EW, Seemer W, Young PM. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. 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. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. As compared to cases in 19952009, those in 20102019 resulted in a significantly higher average nominal payout to plaintiffs ($776,439 $74,460 vs $1,506,000 $385,527, p = 0.028). 16. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. 2013;32(1):111119. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. 13. 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. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. All the operations were done by one surgeon (PK). (A) Anteroposterior and (B) lateral radiographs taken 1 year after surgery show upper screw breakage in the application of a short Cotrel-Dubousset construct in a T12 burst fracture. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. 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. Your message has been successfully sent to your colleague. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. 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The accuracy of pedicle screw placement using intraoperative image guidance systems. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. 2014;20(6):636643. 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. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. 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. In the remaining patients, the standard construct was three-segment fixation spanning four vertebrae and three discs, two above and one below the fractured vertebra, using six screws. 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. 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. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). 2013;34(6):699705. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. shooting in valdosta leaves one dead Seven hundred sixty-three screws were inserted in 138 patients. 14. 144 Am J Transl Res. You may be trying to access this site from a secured browser on the server. However, only a few complications were related to a poor clinical outcome. Some error has occurred while processing your request. One hundred twelve consecutive patients were entered into a retrospective study of instrumented thoracolumbar, lumbar, and lumbosacral spinal arthrodesis at our institution, between September 1994 and January 1999. 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. 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. Clin Orthop 203:717, 1986. Data is temporarily unavailable. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine.
Delayed open treatment of aortic penetration by a thoracic pedicle Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. 28. Orthopedics. 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). Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. Wolters Kluwer Health
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. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Can Postoperative Radiographs Accurately Identify Screw Misplacements? $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West.
Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR 2014;21(3):320328. Review of neurosurgery medical professional liability claims in the United States. Spine 16(8 Suppl):S455458, 1991. Department of Neurosurgery, Spine Division, Duke University Medical Center, Durham, North Carolina; and, Malpractice liability and defensive medicine: a national survey of neurosurgeons, Defensive medicine among high-risk specialist physicians in a volatile malpractice environment, Defensive medicine: a culprit in spiking healthcare costs, Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study, Defensive medicine in U.S. spine neurosurgery, Personal consequences of malpractice lawsuits on American surgeons. doi: 10.1097/BPO.0000000000001828. 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 misplacement rate of more than 20 % (129 misplaced screws out of 608) seems to be unacceptable compared to only 4.5 % misplacements when using CT-navigation leading to the conclusion that pedicle screw instrumentation in the middle and upper thoracic area should be carried out with the help of navigation only. All case demographics are summarized in Table 1. Plaintiff-awarded cases by US region (left). Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 things to know Spine Monday, May 7th, 2018 Post Listen Text Size On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. One of the common means of doing so is to place a screw into each of two adjacent spinal bones (vertebrae), and then a rod between them. 2. Judgment information associated with a defendant (surgeon) versus plaintiff (patient) ruling, trial versus settlement versus arbitration decision, award amount, and time to decision or case closure from index surgery was also recorded. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. The patient had to undergo a subsequent surgery to remove the pedicles. 4. Intraoperative pedicle fractures requiring further points of fixation. Unable to load your collection due to an error, Unable to load your delegates due to an error. Potential complications may include increased pain, infection, or mechanical . Schatlo B, Molliqaj G, Cuvinciuc V, et al. Statistical analysis: Sankey. Rovit RL, Simon AS, Drew J, et al. N Engl J Med. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. J Bone Joint Surg 61A:201207, 1979. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. 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.