pedicle screw misplacement malpractice pedicle screw misplacement malpractice

It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. One hundred four of the 112 patients had a posterior procedure. 2 One of the first obstacles regarding . 5. 2012;89(10):7071. reporting that the number of Medicare patients who underwent a complex lumbar spine fusion for spinal stenosis increased 15-fold, from 1.3 persons per 100,000 Medicare persons in 2002 to 19.9 in 2007.31 Similarly, a study by Rajaee et al. 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. 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. $ = US$. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. 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. In the other patient, L4L5 float arthrodesis was done. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Results: A total of 2724 screws were placed in 127 patients. Svider PF, Husain Q, Kovalerchik O, et al. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. 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. 2012;37(1):6776. Forty-seven general complications were seen in 41 patients (36.5%). States were then grouped by US region and case year by 5-year intervals. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. 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. Ann Thorac Surg. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. 2009;10(1):3339. Materials and Methods Sixty . 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. Many technological advances have been made over the past several decades in an effort to improve the accuracy of screw placement in spine surgery.3436 For example, 3D fluoroscopybased image guidance has been shown to decrease the pedicle breach rate in several studies compared to the rate with 2D fluoroscopic guidance or the freehand technique, particularly in deformity and revision surgeries.21,34,36,37 CT guidance or intraoperative confirmation has also been shown to further improve the accuracy of pedicle screw placement,3638 with reported accuracy rates of 89%100% reported in the literature, depending on the authors breach criteria.35 However, it is important to note that the use of this technology is often accompanied by a lower threshold for intraoperative screw revision, sometimes leading to higher rates of replaced screws.33 Arguably, these improved trajectories may avoid iatrogenic neurological deficits due to prolonged nerve root compression or even improve the stability of the construct;34,37 however, prospective studies of long-term outcomes and rates of revision surgery remain sparse in the literature. 2,24,28,36. The plaintiff received $2.4 million for pain and suffering and loss of enjoyment of life, $2 million for lost income and approximately $123,000 for medical expenses. 15. Spine 19:25842589, 1994. Hardware-related failures were observed in 12 patients (10.7%). This patient recovered completely in 6 weeks. Spine 16(8 Suppl):S422427, 1991. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. Spine 8:970981, 1996. J Neurosurg Spine. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. 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). 2019;19(7):12211231. 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. West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. Wolters Kluwer Health Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Deyo RA, Mirza SK, Martin BI. 22. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. General complications were considered those developing during and after surgery that were not directly related to instrumentation. To prevent general complications, it is evident that precise and careful soft tissue handling, proper irrigation, and debridement during and after surgery, decrease of operative time, and proper patient monitoring postoperatively must be done. In six of these patients with injuries at the thoracolumbar area (four patients with bent screws and two patients with broken screws), the loss of correction ranged from 3 to 4.5 without change of anatomic reduction (Fig 1). 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. Studdert DM, Mello MM, Sage WM, et al. All the incidental dural tears were repaired immediately and produced no clinical sequelae. 2. 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. All Rights Reserved. 28. (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. Results. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. 3. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. However, the misplacement of pedicle screws can lead to disastrous complications because of the close proximity to neural tissue and the surrounding vessels, although rare, serious complications have been reported, such as dural tear, nerve-root irritation, neural injury . Would you like email updates of new search results? single homes for sale in lehigh valley, pa single homes for sale in lehigh valley, pa Home Realizacje i porady Bez kategorii single homes for sale in lehigh valley, pa Schatlo B, Molliqaj G, Cuvinciuc V, et al. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. Spine 16(8 Suppl):S455458, 1991. Moffatt-Bruce SD, Ferdinand FD, Fann JI. Fortunately, most of the complications were minor and transient. Unable to load your collection due to an error, Unable to load your delegates due to an error. 4. J Neurosurg Spine. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. 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. Clinical Orthopaedics and Related Research411:86-94, June 2003. Insuring spinal neurosurgery. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. Nahed BV, Babu MA, Smith TR, Heary RF. 24. 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. National Library of Medicine Defensive medicine in neurosurgery: the Canadian experience. All the operations were done by one surgeon (PK). In order to prove medical malpractice occurred, the plaintiffs attorney needs to show not only the plaintiff experienced a poor medical outcome, but that it was directly caused by medical negligence. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. J Neurosurg. Neurosurgical practice liability: relative risk by procedure type. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. Jena AB, Seabury S, Lakdawalla D, Chandra A. Spinal fusion procedures are increasingly performed each year, with Deyo et al. 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. Your message has been successfully sent to your colleague. 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). 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. Methods. 2017;42(3):177185. HHS Vulnerability Disclosure, Help 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. concluded that the robot-assisted technique was significantly more accurate than the traditional freehand technique.39 Despite the learning curve and initial cost of obtaining technologies such as 3D fluoroscopic devices, intraoperative CT, or robotic navigational systems, the routine use of these technologies for intraoperative imaging confirmation and potential revision of misplaced screws may help spine surgeons avoid inadvertent iatrogenic morbidity for their patients and potential litigation. Spine 18:983991, 1993. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) 2. laterally placed screws and the azygous vein on the right (T5-T11). 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. Balch CM, Oreskovich MR, Dyrbye LN, et al. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. shooting in valdosta leaves one dead Smith TR, Hulou MM, Yan SC, et al. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. Fishers exact test and the Mann-Whitney U-test were used for the analysis of categorical and continuous data, respectively, except when an unpaired t-test was utilized for analyses related to normalized, nominal, and inflation-adjusted award totals. The majority of screws were misplaced in the lumbar spine for both plaintiff- and defendant-awarded cases (66.7% vs 57.4%, respectively, p = 0.564; Table 1). Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. 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). Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Several limitations should be carefully considered when interpreting our results. 29. 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. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. 2020;162(6):13791387. Orthopedics. Clin Orthop 284:8090, 1992. 2018;41(5):e615e620. Analysis and interpretation of data: Sankey, TT Than. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. Seven hundred sixty-three screws were inserted in 138 patients. 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. Conversely, Nyquists foot drop did not resolve after the screw was removed, which begged the question of whether the foot drop was in fact caused by the misplaced screw. 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). Conclusion: 2005;293(21):26092617. An official website of the United States government. EOS System Courtesy of EOS imaging. 6. Epub 2014 Apr 4. Dr. Abd-El-Barr is a consultant for Spineology. Five patients had uneventful early postoperative course. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Re: malpositioned pedicle screw resulting in additional surgery and disability. Of note, the award amount for one settlement case was undisclosed. The medicolegal landscape of spine surgery: how do surgeons fare? 11. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. JAMA. A.J. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Plaintiff-awarded cases by US region (left). 25. Agarwal N, Gupta R, Agarwal P, et al. 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. 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). Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. Cerebrospinal fluid fistulas. J Am Coll Surg. You are talking one of the most complicated area of the law. Statistical analysis: Sankey. 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. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. However, only a few complications were related to a poor clinical outcome. 2011;306(10):1088. Characteristics of medicolegal cases related to misplaced screws in spine surgery. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. 8. Rovit RL, Simon AS, Drew J, et al. The rate of medical complications was 8%. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. The medicolegal landscape of spine surgery: how do surgeons fare? Similar to our findings, prior studies have shown that settlements result in lower payouts than cases that are ultimately taken to trial,7,14,15,30 with awards ranging from $125,000 to $9,000,000 compared to $134,000 to more than $38,000,000.7,15 Nevertheless, the true financial toll on spine surgery is largely unknown given that 85% of cases are dismissed or settled out of court, with undisclosed amounts.14 Likewise, substantial time is spent and costs, including legal and administrative, are incurred before judgment, as noted above. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. Percentage of cases per US region (center). Bookshelf J Pediatr Orthop. Surg Neurol. Potential complications may include increased pain, infection, or mechanical . 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. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Likewise, research shows that breaches still occur when these tools are used,33,40 and some studies did not find a difference in pedicle breach rates compared to those with traditional fluoroscopic and freehand techniques.33 Ultimately, misplaced instrumentation is a risk of any spinal fusion surgery, and a thorough discussion of these risks, as well as the alternative management options, is essential to maintain high-quality patient care and to avoid litigation. Both of these patients complained of thigh pain but refused any additional surgery. 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. Spine 6:615619, 1981. Din RS, Yan SC, Cote DJ, et al. 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. Federal government websites often end in .gov or .mil. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion.