pedicle screw misplacement malpractice

Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. your express consent. Malpractice issues in neurological surgery. The average age of the patients was 47 years and the average followup was 35 months. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 2020;162(6):13791387. laterally placed screws and the azygous vein on the right (T5-T11). This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. An official website of the United States government. States were then grouped by US region and case year by 5-year intervals. What can spine surgeons do to improve patient care and avoid medical negligence suits? Re: malpositioned pedicle screw resulting in additional surgery and disability. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. 2020;11:38. 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. All the operations were done by one surgeon (PK). 2016;102(2):358362. Clin Orthop 284:8090, 1992. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. 2013;32(1):111119. You are talking one of the most complicated area of the law. 2. 2. J Bone Joint Surg 73A:11791184, 1991. 35. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. 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. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. In addition, studies have shown that over 85% of malpractice claims are either dismissed or settled out of court,14 which likely results in a high degree of underreporting. 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. 2019;19(7):12211231. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. All Rights Reserved. Nottmeier EW, Seemer W, Young PM. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. 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. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). West et al 33 also reported a 29% complication rate for the first 50 patients and a 26% complication rate for the last 74 patients. Neurosurgical practice liability: relative risk by procedure type. 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. J Spine Surg. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. Although the rate of the reported medical complications was high (36.5%), these did not significantly affect the final clinical outcome of the current patients. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. 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. ObjectThe goal of this study was to determine the incidence of screw misplacement and complications in a group of 102 patients who underwent transpedicle screw fixation in the lumbosacral spine with conventional open technique and intraoperative. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. Spine (Phila Pa 1976). Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. Spine J. The average followup was 35 months (range, 1851 months). shooting in valdosta leaves one dead Fortunately, most of the complications were minor and transient. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Results. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. 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 Pitfall: Unstable injuries. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. 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. Of note, the award amount for one settlement case was undisclosed. Epub 2021 Aug 28. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. Yuan et al 37 reported that the use of spinal instrumentation is associated with higher rate of infection (3%6%), neurologic injury (1%5%), instrumentation failure (6%10%), and reoperation (20%), compared with in situ arthrodeses. 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. I won't be at the office but I will check my voice mail. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. In their meta-analysis of nine randomized controlled trials, Li et al. Spine (Phila Pa 1976). N Engl J Med. 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. 27. 4. 2012;37(1):6776. Spine 13:10121018, 1988. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. 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. A total of 2396 screws were placed accurately (87.96%). government site. Screw misplacement. Nayar G, Blizzard DJ, Wang TY, et al. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. 2005;293(21):26092617. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. 2009;10(1):3339. (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. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. 2012 Feb 1;37(3):E188-94. Am J Orthop. Am J Otolaryngol. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. 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. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. 15. Arthrodesis was questionable in eight asymptomatic patients (7.1%). Copyright 2023 Becker's Healthcare. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. 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). This retrospective analysis of 68 closed medicolegal cases related to misplaced screws in spine surgery showed that neurosurgeons and orthopedic spine surgeons were equally named as the defendant (n = 32 and 31, respectively), and cases were most commonly due to misplaced lumbar pedicle screws (n = 41, 60.3%). Accuracy of C2 pedicle screw placement using the anatomic freehand technique. 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. 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. 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. Routine CT scans were taken in all patients. Spinal fusion procedures are increasingly performed each year, with Deyo et al. Rovit RL, Simon AS, Drew J, et al. Pedicle screw construct have become one of the most practiced procedure in spinal 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. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. 2 One of the first obstacles regarding . 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. J Pediatr Orthop. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. 2018;27(9):23392347. Under the high-low agreement, Drs. 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. Nahed BV, Babu MA, Smith TR, Heary RF. (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. However, the highest offer had been a combined $300,000 from the two defendants. Analysis and interpretation of data: Sankey, TT Than. All case demographics are summarized in Table 1. 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%. It is indicated that screws medially misplaced at a distance greater than 2-mm, especially 4 mm, may be a cause of negative effects on the neural structure and should be removed during the early phase of the postoperative period, even among patients without postoperative neurological abnormalities. Materials and Methods Sixty . Thu, May 27th, 2021. 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). 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. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. Federal government websites often end in .gov or .mil. 1. 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). The accuracy of pedicle screw placement using intraoperative image guidance systems. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? 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. Malpractice liability and defensive medicine: a national survey of neurosurgeons. Conception and design: Sankey, KD Than. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. Hardware problems were those related to the physical change of metal and screw position. South Med J 62:17, 1969. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. Your current browser may not support copying via this button. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. Clin Orthop 203:717, 1986. Methods. 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. None of these complications resulted in additional surgery or in a significant increase of morbidity. 2011;24(1):1519. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. 8600 Rockville Pike 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 fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. Some error has occurred while processing your request. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Laryngoscope. Spine (Phila Pa 1976). Cookie Policy. Objective: Of note, the award amount for one settlement case was undisclosed. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Intraoperative pedicle fractures requiring further points of fixation. 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. 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. 20th Annual Spine, Orthopedic & Pain Management-Driven ASC Conference, 8th Annual Health IT + Digital Health + RCM Conference, 29th Annual Meeting - The Business & Operations of ASCs, The issues spine surgeons are advocating for outside of the operating room, Centinel Spine is now covered by all major payers, What's next for SI joint fusion? . Orthopedics. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. J Neurosurg Spine. 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 . Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. 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. A total of 69 patients (mean age, 67.416 . ABSTRACT: Pedicle screw loosening has been implicated in recurrent back pain after lumbar spinal fusion, but the degree of loosening has not been systematically quantied in patients. 5. Percentage of cases per US region (center). 2012;89(10):7071. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Neurosurgery. Facebook Google Plus Youtube RSS Email. 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. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. Taylor CL. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). The third patient, who had central spinal stenosis, was treated by decompression alone. Pedicle screw placement is a common procedure. Five patients had uneventful early postoperative course. Several studies reveal that fusion rates increase when rigid internal fixation is used, 14,20,21,33,38 and that by using pedicle screws and plates or rods for stabilization, spinal arthrodesis can be limited to the disease segments. Ahmadi SA, Sadat H, Scheufler KM, et al. Reviewed submitted version of manuscript: all authors. 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.

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