This patient recovered completely in 6 weeks. The pedicle screw system is widely used in spine surgery, and it provides rigid fixation and leads to successful subsequent deformity correction and bony fusion. The screws were needed to stabilize the spine and fix the fused vertebrae in place. The patient had subsequent coronal imbalance and degeneration of the upper disc. Pullout performance comparison of pedicle screws based on cement application and design parameters Tolga Tolunay, Cemile Bagl, Teyfik Demir, Mesut E Yaman, and Arslan K Arslan Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 2015 229: 11 , 786-793 Download Citation may email you for journal alerts and information, but is committed Spine 17:834837, 1992. Under this theory of liability, the plaintiff needed to not only establish that she had experienced foot drop, a fact that no one was disputing, but that it was caused by the defendants negligence. Median screw misplacement rate was 10% in group A and 13% in group B. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. Malpractice litigation following spine surgery. The most frequent primary injury listed for a lawsuit was nerve root injury, present in 81.0% (n = 17) and 74.5% (n = 35) of plaintiff- and defendant-awarded cases, respectively (p = 0.7). Conception and design: Sankey, KD Than. J Am Coll Surg. 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). 2014;174(11):18671868. The cost of defensive medicine on 3 hospital medicine services, Defensive medicine in neurosurgery: the Canadian experience, Review of neurosurgery medical professional liability claims in the United States, A nine-year review of medicolegal claims in neurosurgery, Malpractice risk according to physician specialty, Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003, Descriptive analysis of state and federal spine surgery malpractice litigation in the United States, Malpractice litigation following spine surgery, Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis, Malpractice claims in spine surgery in Germany: a 5-year analysis, On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim, Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England, Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort, It is easier to confuse a jury than convince a judge: the crisis in medical malpractice, Determining legal responsibility in otolaryngology: a review of 44 trials since 2008, Legal liability in iatrogenic orbital injury, Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study, Malpractice issues in neurological surgery. 2017;42(3):177185. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. 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. Surg Neurol. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). 2. In White AH, Rothman RH, Ray CD (eds). A retrospective review of closed medicolegal cases with verdicts or settlements between 1995 and 2019 was performed using the Westlaw Edge legal research database (Thomson Reuters).7,14,16,23,24 A search of closed federal and state malpractice claims within the Verdicts and Settlements section consisted of the following: spine and surgery and pedicle and screw and fusion and (misplaced or misguided or mispositioned) and surgeon. Inclusion criteria consisted of malpractice claims against surgeons for complications related to misplaced pedicle and/or lateral mass screws. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. 18. 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. Spine 13:10121018, 1988. 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. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. 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. Lumbosacral pedicle screw placement using a fluoroscopic pedicle axis Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. 26. J Bone Joint Surg 45A:11591170, 1963. Plaintiff-awarded cases by US region (left). Data is temporarily unavailable. Some error has occurred while processing your request. 15. 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. 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. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. 25. Neurological outcome and management of pedicle screws - PubMed Nottmeier EW, Seemer W, Young PM. Spine 6:263267, 1981. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. A rod is used to hold the vertebra together to allow fusion to occur. The pedicle screws judged as misplacement. a Medial minor perforation A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. 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. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. Spine (Phila Pa 1976). All the incidental dural tears were repaired immediately and produced no clinical sequelae. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. 5-7 Materials and Methods This is a retrospective study of kyphotic spondylitis tuberculosis (Stb) patients conducted at Fatmawati General Hospital, Jakarta, Indonesia, through the year 2020-2021. Cookie Policy. Mason A, Paulsen R, Babuska JM, et al. 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. Agarwal N, Gupta R, Agarwal P, et al. (PDF) Accuracy of pedicle screw placement in the lumbosacral spine doi: 10.1097/BRS.0b013e31822a2e0a. 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). Presse Med 78:14471448, 1970. Linking and Reprinting Policy. 2,24,28,36. 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. 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. 14. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. Spinal fusion procedures are increasingly performed each year, with Deyo et al. CT-navigation versus fluoroscopy-guided placement of pedicle screws at 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). 2020;11:38. 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. Pedicle screw insertion techniques: an update and review of the Nayar G, Blizzard DJ, Wang TY, et al. pedicle screw misplacement malpractice. Potential complications may include increased pain, infection, or mechanical . Reoperation for Misplaced Pedicle Screws: A Multicenter Retrospec Drs. Please enable it to take advantage of the complete set of features! 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. Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. Privacy Policy. While the majority of verdicts are found in favor of the defendant (surgeon), over 30% of cases in this study were found in favor of the plaintiff (patient), resulting in average inflation-adjusted payouts of over $1.2 million per claim over the past 25 years. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. 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. 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. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Clin Orthop 203:126134, 1986. 10. 11. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. Ann R Coll Surg Engl. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. The third patient, who had central spinal stenosis, was treated by decompression alone. 2014;96(4):266270. Per-patient analysis reveals more concerning numbers toward screw misplacement. 2. A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. Med Econ. The medicolegal landscape of spine surgery: how do surgeons fare? (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. J Neurosurg. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. The .gov means its official. You may be trying to access this site from a secured browser on the server. The link was not copied. Scarone P, Vincenzo G, Distefano D, et al. The site is secure. Epub 2022 Oct 29. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. Luque ER: Segmental spinal instrumentation of lumbar spine. 5 Those authors recommend that particular care should be taken in inserting the washers without cross threading and ensuring that they are locked down tightly, with an adequate length of rod protruding beyond the screw. 15. single homes for sale in lehigh valley, pa Todd NV. J Bone Joint Surg 73A:11791184, 1991. However, published reports are increasingly demonstrative of the positive effect of pedicle fixation on arthrodesis and successful outcome in the treatment of patients with these disorders. Results: A total of 2724 screws were placed in 127 patients. 1. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. 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. government site. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. to maintaining your privacy and will not share your personal information without I won't be at the office but I will check my voice mail. 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. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. Malpractice liability and defensive medicine: a national survey of neurosurgeons. 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. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. Thus, in the current study we aimed to describe this impact in the US, as well as to suggest a potential method for mitigating the problem. Pedicle screw insertion in the thoracolumbar spine. Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. 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. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. J Neurosurg Spine. Results: Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. South Med J 62:17, 1969. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. 12. 8,24,25,32. You are talking one of the most complicated area of the law. Conclusion: Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. Neurologic injury. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. J Pediatr Orthop. Spine 13:696706, 1988. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Deyo RA, Mirza SK, Martin BI. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. J Neurosurg Spine. Br J Neurosurg. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 Materials and Methods Sixty . Malpractice issues in neurological surgery. J Neurosurg Spine. 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. Through the use of expert witness testimony, Mr. da Costa was able to prove to the jury that by misplacing the pedicle screw during the surgery, and failing to timely diagnose and correct the malpositioned screw, Defendants deviated from accepted standards of care. Clipboard, Search History, and several other advanced features are temporarily unavailable. 1. All the operations were done by one surgeon (PK). Of note, the award amount for one settlement case was undisclosed. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Spine (Phila Pa 1976). Ann Thorac Surg. Retrospective Computed Tomography Scan Analysis of Percutaneously 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. 2018;41(5):e615e620. 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. Dr. Shaffrey has received grants from the NIH and Department of Defense. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction were excluded from analysis. Clin Orthop 203:7598, 1986. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. In this example, the surgeon replaced the misplaced screw prior to leaving the operating room, which arguably played a significant role in the jury ruling in favor of the defendant (surgeon). In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. 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. 2020;162(6):13791387. Clinical Orthopaedics and Related Research411:86-94, June 2003. official website and that any information you provide is encrypted Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. Plaintiff award amounts were adjusted for inflation as of April 2020 using an online inflation calculator provided by the US Bureau of Labor Statistics (https://www.bls.gov/data/inflation_calculator.htm). 2022 Sep 15;14(9):6323-6331. eCollection 2022. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. Int Orthop 20:3542, 1996. $ = US$. Partner, Paul M. da Costa, Obtains $4.5 Million Verdict - Snyder Sarno Defensive medicine in U.S. spine neurosurgery. 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. J Bone Joint Surg 61A:201207, 1979. Makhni MC, Park PJ, Jimenez J, et al. 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. Re: malpositioned pedicle screw resulting in additional surgery and disability. J Neurosurg Spine. Malpractice risk according to physician specialty. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. Clin Orthop 203:717, 1986. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Comparison of pedicle screw placement accuracy between two types of 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. $2 Million Spinal Surgery Case Against Neurosurgeon and Hospital 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. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Robotic-assisted pedicle screw placement fails to reduce overall We attribute the 24.1% disc space narrowing in the instrumented segments mainly to the severe injury of the disc and communication of the end plate in burst fractures, which could accelerate the disc degeneration and narrowing. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. 2013;32(1):111119. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. 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. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). 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. Pedicle screws are used by spine surgeons as part of a fusion in which two adjacent bones in the spine are combined together as one. All Rights Reserved. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. The accuracy of pedicle screw placement using intraoperative image guidance systems. General complications were considered those developing during and after surgery that were not directly related to instrumentation. Schatlo B, Molliqaj G, Cuvinciuc V, et al. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. 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. Of note, the award amount for one settlement case was undisclosed. + 48 696 042 504. Moffatt-Bruce SD, Ferdinand FD, Fann JI. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. 29. 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.