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Segal J. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. 2016;102(2):358362. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. Epub 2014 Apr 4. MeSH 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. Deyo RA, Mirza SK, Martin BI. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. 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. Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. 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. Results. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. Acta Neurochir (Wien). 18. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. Clin Orthop 284:8090, 1992. Analysis and interpretation of data: Sankey, TT Than. Malpractice litigation following spine surgery. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. 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. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. 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. What can spine surgeons do to improve patient care and avoid medical negligence suits? Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. This patient recovered completely in 6 weeks. Spinal fusion in the United States: analysis of trends from 1998 to 2008. 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. 34. You are talking one of the most complicated area of the law. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. 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). Bethesda, MD 20894, Web Policies The link was not copied. Seven hundred sixty-three screws were inserted in 138 patients. The rate of reoperation for screw misplacement per screw was 0.17%. Results: A total of 2724 screws were placed in 127 patients. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. 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. Re: malpositioned pedicle screw resulting in additional surgery and disability. Each side was judged separately. Br J Neurosurg. were excluded from analysis. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Spine 16(8 Suppl):S455458, 1991. 2011;365(7):629636. Spinal fusion procedures are increasingly performed each year, with Deyo et al. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). However, the misplacement of pedicle screws can lead to disastrous complications. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. doi: 10.1097/BPO.0000000000001828. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Several studies have shown that spine surgery is at the highest risk for litigation among the surgical subspecialties.12,29 The majority of claims are related to technical and procedural errors,29 including misplaced pedicle and/or lateral mass screws. Despite these failures, solid spinal arthrodesis was obtained in all patients. Please try after some time. Conclusion: Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. What can spine surgeons do to improve patient care and avoid medical negligence suits? In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. Rovit RL, Simon AS, Drew J, et al. 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. $ = US$. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. However, only a few complications were related to a poor clinical outcome. Introduction. Except for the patient with an infected pseudarthrosis who had a flat back syndrome (sagittal imbalance) develop, coronal imbalance was observed in five patients (4.5%), and ranged from 7.5 to 12 (Fig 3). Spine 13:696706, 1988. Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . your express consent. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. It has a great developing technique that is used for fixation and fusion in spine surgery. The third patient, who had central spinal stenosis, was treated by decompression alone. 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). 4). Epstein NE. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Thankfully, most screws are just misplaced by a millimeter or two out the front or are slightly off medially, so they are not doing real damage. Nottmeier EW, Seemer W, Young PM. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. 4. Background The objective of this cadaveric study was to analyze the effects of iatrogenic pedicle perforations from screw misplacement on the mean pullout strength of lower thoracic and lumbar pedicle screws. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Spine (Phila Pa 1976). St Louis, CV Mosby 322327, 1987. I won't be at the office but I will check my voice mail. Smith TR, Hulou MM, Yan SC, et al. 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. 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. Critically revising the article: all authors. 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. 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. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. Studdert DM, Mello MM, Sage WM, et al. 1. 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. 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. The remaining eight patients, including two patients with spinal trauma, five patients with infection, and one patient with a tumor, had anterior and posterior procedures. Forty-seven general complications were seen in 41 patients (36.5%). All the operations were done by one surgeon (PK). reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. 26. One hundred four of the 112 patients had a posterior procedure. J Neurosurg Spine. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. Arthrodesis was questionable in eight asymptomatic patients (7.1%). Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. 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). 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. 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. To prevent the development of pseudarthrosis, we think it is important for surgeons to apply the following five technical principles: the proper-sized pedicle screw has to be inserted on the first attempt; repeated manipulation in setting instruments must be avoided; anterior penetration of the screw into the sacrum and insertion of two screws in each side are advocated for fixing the lumbosacral junction; industrious and detailed decortication of the posterior elements must be developed fully; and the use of autologous bone graft is recommended. Defensive medicine in neurosurgery: the Canadian experience. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. Agarwal N, Gupta R, Agarwal P, et al. Privacy Policy. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. Spine (Phila Pa 1976). PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . 2013;32(1):111119. Defendant-awarded cases by US region (right). Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). Spine fixation included one segment in 27 patients, two segments in 38 patients, three segments in 42 patients, and more than three segments in five patients. 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. J Neurosurg Spine. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. For more information, please refer to our Privacy Policy. In five patients with thoracolumbar injuries, who were the first treated in the current series, and in four patients with fractures in the lower lumbar spine, two-segment fixation was used. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. Ann Thorac Surg. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. Per-patient analysis reveals more concerning numbers toward screw misplacement. NCI CPTC Antibody Characterization Program. The patient had to undergo a subsequent surgery to remove the pedicles. 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. 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. N Engl J Med. JAMA Intern Med. 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. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw.