pedicle screw misplacement malpractice
However, the highest offer had been a combined $300,000 from the two defendants. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. 10. Reviewed submitted version of manuscript: all authors. Results: A total of 2724 screws were placed in 127 patients. The average followup was 35 months (range, 1851 months). 2009;10(1):3339. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. 2016;102(2):358362. 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. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. 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. Drs. Spine 18:983991, 1993. 2013;32(1):111119. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. Eur Spine J. 2006;65(4):416421. Please try after some time. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. The site is secure. At the trials close, the plaintiffs attorney had asked the jury to return a $5.3 million verdict and had made a prior demand to settle the medical malpractice lawsuit for $1 million. Thus, meaningful efforts to limit the rate of misplaced pedicle and lateral mass screws, such as the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation, should be carefully considered. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . 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. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. 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. 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. 2018;83(5):9971006. Am J Transl Res. 2. I won't be at the office but I will check my voice mail. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. J Neurosurg Spine. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? 2020;162(6):13791387. Wolters Kluwer Health Defensive medicine: a culprit in spiking healthcare costs. Per-patient analysis reveals more concerning numbers toward screw misplacement. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Under the high-low agreement, Drs. * A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 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. Clin Orthop 203:4553, 1986. Clinical Orthopaedics and Related Research411:86-94, June 2003. Call me tomorrow. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. . The contact form sends information by non-encrypted email, which is not secure. In several of the studies in the spinal literature, the contention that instrumentation improves arthrodesis rates, considering that nonunion contributes to a poor outcome in spinal arthrodesis is favored. 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. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. Five patients had uneventful early postoperative course. Patient-specific 3D-printed surgical guides for pedicle screw insertion Copyright © 2023 Becker's Healthcare. 2012;37(1):6776. 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. Each case was then carefully screened for relevance and sufficient data. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. (PDF) Lumbosacral pedicle screw placement using a fluoroscopic pedicle $2 Million Spinal Surgery Case Against Neurosurgeon and Hospital A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. and 17.1% of the patients included had at least one screw misplaced. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. 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. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). Median screw misplacement rate was 10% in group A and 13% in group B. 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. Steffee AD, Biscup RS, Sitkowski DJ: Segmental spine plates with pedicle screw fixation: A new internal fixation device for disorders of the lumbar and thoracolumbar spine. Patient safety: disclosure of medical errors and risk mitigation. HHS Vulnerability Disclosure, Help 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. 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. Defensive medicine in U.S. spine neurosurgery. This site needs JavaScript to work properly. Jury Verdict for Doctor for Screw Allegedly Misplaced During Lumbar Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. South Med J 62:17, 1969. J Neurosurg. Bydon M, Xu R, Amin AG, et al. Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. 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). Two-dimensional (2D) fluoroscopy-guided percutaneous pedicle screw (PPS) placement is currently the most widely applied instrumentation for minimally invasive treatment of spinal injuries requiring stabilization. Also notable, only one claim reported the use of intraoperative CT and was ultimately ruled in favor of the defendant. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. 2014;20(2):196203. 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. 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. Review of neurosurgery medical professional liability claims in the United States. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. JAMA Intern Med. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. Can Postoperative Radiographs Accurately Identify Screw Misplacements? Of note, the award amount for one settlement case was undisclosed. 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. 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. Image intensification and the technique recommended by Weinstein et al 32 was used for screw placement in the lumbar vertebrae, whereas Chopin blocks (Medtronic Sofamor Danek) with two screws diverging bilaterally were used for sacral fixation. Materials and Methods Sixty . 2020;11:38. 19. 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. (PDF) Accuracy of pedicle screw placement in the lumbosacral spine 17. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. Clin Orthop 203:126134, 1986. Taylor CL. 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). 2012;89(10):7071. PMC Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Analysis and interpretation of data: Sankey, TT Than. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. Hardware-related failures were observed in 12 patients (10.7%). Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. The largest inflation-adjusted payout awarded to the plaintiff ($3,372,185) for nerve root injury occurred in a 36-year-old male who had undergone an L4S1 posterior spinal fusion, which resulted in permanent and direct injury to right L5 and S1 nerve roots, with foot drop and radiculopathy. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). 2013;123(9):20992103. 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. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. Spine J. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. 27. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. Spinal fusion in the United States: analysis of trends from 1998 to 2008. 4). Complications and Problems Related to Pedicle Screw Fixation - LWW Spine 16(8 Suppl):S422427, 1991. J Bone Joint Surg 61A:201207, 1979. Thu, May 27th, 2021. This occurred on only one side and the correction achieved by the instrumentation was maintained. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. A total of 69 patients (mean age, 67.416 . Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. The rate of reoperation for screw misplacement per screw was 0.17%. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. 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. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. Results: Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. 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. Malpractice issues in neurological surgery. 5. 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. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). The initial search using the terms above returned 3654 cases. 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. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. 2019;19(7):12211231. The plaintiff underwent revision surgery in May 2013. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. While reported to be one of the best legal research resources available and utilized in several previous studies,7,14,16,23,24 available court documents and clinical/operative details are highly variable and greatly limited among case files. 2. However, the misplacement of pedicle screws can lead to disastrous complications. + 48 696 042 504. The .gov means its official. Conception and design: Sankey, KD Than. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. J Spinal Disord Tech. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. 2016;25(3):716723. Eur Spine J. 35. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. 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. Administrative/technical/material support: Mehta, Wang, KD Than. 6 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. 2014;174(11):18671868. Forty-seven general complications were seen in 41 patients (36.5%). 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. official website and that any information you provide is encrypted Pedicle Screw Malposition Expert Witness: Malposition Can Lead to 2016;124(5):15241530. 3. 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. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. 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. Spine 13:952953, 1988. 30. 3). haroinfather roblox id Agarwal N, Gupta R, Agarwal P, et al. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. 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. Disclaimer. Neurological Outcome and Management of Pedicle Screws Misplaced Totally The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. All the operations were done by one surgeon (PK). This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Spine 15:908912, 1990. Spine (Phila Pa 1976). 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. Todd NV. Fortunately, most of the complications were minor and transient. 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. 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. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. However, the misplacement of pedicle screws can lead to disastrous complications. Orthopedics. Please enable scripts and reload this page. Thoracic pedicle screw placement: Free-hand technique - Bioline Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. None of these complications resulted in additional surgery or in a significant increase of morbidity. Objective: Spine (Phila Pa 1976). Li HM, Zhang RJ, Shen CL. Acta Neurochir (Wien). The pedicle screws judged as misplacement. a Medial minor perforation Neurosurgical practice liability: relative risk by procedure type. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. Spine 6:263267, 1981. Spine 17:834837, 1992. Spine 18:18621866, 1993. Din RS, Yan SC, Cote DJ, et al. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. 2017;31(3):287288. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. 2014;21(3):320328. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. Scarone P, Vincenzo G, Distefano D, et al. 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