pedicle screw misplacement malpractice

However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. 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). Federal government websites often end in .gov or .mil. 6. A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Please enable scripts and reload this page. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. JAMA. Studies have shown that the greatest proportion of malpractice claims in spine surgery are related to procedural error,10,11,14,16,17,19 often resulting in the highest payouts.11,20 For spine surgery, one common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass screws, which occurs in approximately 14%55% of cases using standard techniques and results in neurological injury and/or durotomy in approximately 1%8% of cases.21 Misplaced screws have the potential to cause severe and sometimes permanent neurological deficits, including spinal cord and/or nerve root injury,21 as well as to decrease the stability of the fusion construct, leading to delayed complications related to pseudarthrosis. Clin Orthop 227:1023, 1988. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Spine 6:263267, 1981. Spine 17:834837, 1992. 11. Instead, the defense offered up an alternative explanation for Nyquists foot drop. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. In four of these patients, bent screws occurred at 8 to 10 months after surgery; in three patients, broken screw necks were seen 1 year after surgery and in two patients, tulip screw plug dislodgments were observed at 4 and 6 months postoperatively, respectively. 2014;21(3):320328. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. 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). Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). Makhni MC, Park PJ, Jimenez J, et al. 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). Defensive medicine: a culprit in spiking healthcare costs. Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. 2013;32(1):111119. 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. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. 19. The third patient, who had central spinal stenosis, was treated by decompression alone. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Lumbar Spine Surgery. official website and that any information you provide is encrypted 2011;213(5):657667. Spine 17:349355, 1992. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. For more information, please refer to our Privacy Policy. Pedicle screw insertion in the thoracolumbar spine. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. 2011;306(10):1088. 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. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Surg Neurol Int. 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. 8,24,25,32. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. (%), Pseudarthrosis requiring revision surgery. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. J Neurosurg Spine. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. Drafting the article: Sankey. 2012;37(1):6776. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. None of these complications resulted in additional surgery or in a significant increase of morbidity. 2016;124(5):15241530. 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. 35. Screw misplacement. Clin Orthop 115:130139, 1976. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. The patient had to undergo a subsequent surgery to remove the pedicles. 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. 2006;65(4):416421. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). Summary of background data: Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. Percentage of cases per US region (center). reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. 3. 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. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. Unauthorized use of these marks is strictly prohibited. A p < 0.05 was considered statistically significant. Fager CA. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. Some error has occurred while processing your request. 32. Spine 18:11601172, 1993. Methods: 20. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. 2016;25(3):716723. J Neurosurg Spine. 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. 14. The plaintiff underwent revision surgery in May 2013. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. 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. Spine 13:10121018, 1988. The rate of medical complications was 8%. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). Epstein NE. The accuracy of pedicle screw placement using intraoperative image guidance systems. The initial search using the terms above returned 3654 cases. Introduction. 10. In addition, hardware failures were observed in 12 patients (10.7%), junctional problems were seen in five patients (4.5%), problems in the instrumented segments were seen in 39 patients (34.7%), and problems of balance occurred in five patients (4.5%). 33. $ = US$. pedicle screws sagittal alignment spinal fusion surgical guides Spinal fusion is used to treat a range of conditions associated with spinal column such as intervertebral disc degeneration and scoliosis [ 1 ]. matte black square deadbolt; roberts point park fishing report; qr code on binax covid test; mff premium character list. 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). The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. 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). J Neurosurg Spine. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. and 17.1% of the patients included had at least one screw misplaced. Li HM, Zhang RJ, Shen CL. J Bone Joint Surg 61A:201207, 1979. 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. 2. Spine (Phila Pa 1976). 2014;75(6):609613. 26. 3. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. Materials and Methods Sixty . 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. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. Rajasekaran S, Bhushan M, Aiyer S, et al. Clin Orthop 203:7598, 1986. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Please try after some time. In White AH, Rothman RH, Ray CD (eds). All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). Guillain A, Moncany AH, Hamel O, et al. These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. 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. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. 2013;34(6):699705. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). 2002;27(22):24252430. Ahmadi SA, Sadat H, Scheufler KM, et al. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. Ann R Coll Surg Engl. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. A total of 2724 screws were placed in 127 patients. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. These numbers are in line with the current literature. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. 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. Don't jump in get legal help. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. The site is secure. 22. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. In the current study, the arthrodesis rate of 89.4% compares favorably with other previously reported series in the spinal literature, most of which use radiographic means to access the status of the spinal arthrodesis. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. A rod is used to hold the vertebra together to allow fusion to occur. Svider PF, Husain Q, Kovalerchik O, et al. 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. Malpractice claims in spine surgery in Germany: a 5-year analysis. 4). Eur Spine J. . HHS Vulnerability Disclosure, Help Epub 2021 Aug 28. 12. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. 27,30 Infected pseudarthrosis developed in one patient (0.9%) with an L4S1 arthrodesis, and the instrumentation was removed 18 months later resulting in a flat back syndrome. Two patients with associated injuries in the lower limbs had deep venous thrombosis develop, three patients had pneumonia develop, and four patients with neurologic impairment had urinary tract infections develop. 28. 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. Facebook Google Plus Youtube RSS Email. 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. 27. 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. 38. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. Under the high-low agreement, Drs. 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. 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. 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). 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. Spine Deform. Sethi MK, Obremskey WT, Natividad H, et al. Please enable it to take advantage of the complete set of features! Epstein NE. 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. Review of neurosurgery medical professional liability claims in the United States. 2,24,28,36. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. Orthopedics. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. States were then grouped by US region and case year by 5-year intervals. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. A total of 69 patients (mean age, 67.416 . The patient suffered permanent nerve damage as a result of the puncture. Routine CT scans were taken in all patients. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. Rothberg MB, Class J, Bishop TF, et al. Taylor CL. 2012;89(10):7071. Each case was then carefully screened for relevance and sufficient data. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. 31. 2013;123(9):20992103. Both of these patients complained of thigh pain but refused any additional surgery. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. Spine 18:18621866, 1993. 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). A.J. A total of 2396 screws were placed accurately (87.96%). Clipboard, Search History, and several other advanced features are temporarily unavailable. 29. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. Drs. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Spine 13:952953, 1988. 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. J Neurosurg Spine. 16. 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. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. 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. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. And while the offending screw was removed the next day, Nyquist continued to experience right foot drop, along with lower back pain and sciatica, i.e. All the incidental dural tears were repaired immediately and produced no clinical sequelae. 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. Am J Otolaryngol. 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. 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). [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. Show more. However, the misplacement of pedicle screws can lead to disastrous complications. 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. 2014;20(6):636643. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures.

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