pedicle screw misplacement malpractice pedicle screw misplacement malpractice

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%. This occurred on only one side and the correction achieved by the instrumentation was maintained. Dr. Shaffrey has received grants from the NIH and Department of Defense. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. J Neurosurg Spine. 32. The plaintiff will recover $2.25 million because of a high-low agreement the lawyers entered after closing arguments, the New Jersey Law Journal reports. 1. One hundred four of the 112 patients had a posterior procedure. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. Unable to load your collection due to an error, Unable to load your delegates due to an error. official website and that any information you provide is encrypted Some error has occurred while processing your request. Patient safety: disclosure of medical errors and risk mitigation. demonstrated that the number of hospital discharges for spinal fusion increased 2.4 times (137%) from 174,223 to 413,171 (p < 0.001) between 1998 and 2008.32 The true frequency of malpositioned pedicle and lateral mass screws is likely underestimated in spine surgery given the fact that the majority of misplaced screws, as well as the potential complications related to them, are not reported in practice and may be clinically silent. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. 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. Neurosurgical practice liability: relative risk by procedure type. Of note, the award amount for one settlement case was undisclosed. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. One of the common means of doing so is to place a screw into each of two adjacent spinal bones (vertebrae), and then a rod between them. Please try again soon. Facebook Google Plus Youtube RSS Email. 2018;83(5):9971006. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. Neurosurgery. Defendant-awarded cases by US region (right). Reviewed submitted version of manuscript: all authors. 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). Through the use of expert witness testimony, Mr. da Costa was able to prove to the jury that by misplacing the pedicle screw during the surgery, and failing to timely diagnose and correct the malpositioned screw, Defendants deviated from accepted standards of care. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. For more information, please refer to our Privacy Policy. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 things to know Spine Monday, May 7th, 2018 Post Listen Text Size On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. Hecht N, Kamphuis M, Czabanka M, et al. In the other patient, L4L5 float arthrodesis was done. The amount awarded was not significantly different across US regions (p = 0.9; Fig. Svider PF, Kovalerchik O, Mauro AC, et al. Summary of background data: 2002;27(22):24252430. A p < 0.05 was considered statistically significant. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. 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. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. What can spine surgeons do to improve patient care and avoid medical negligence suits? 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. 31. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. Methods: Clin Orthop 203:717, 1986. Routine CT scans were taken in all patients. Each case was then carefully screened for relevance and sufficient data. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. Spine (Phila Pa 1976). There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). Personal consequences of malpractice lawsuits on American surgeons. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. A total of 2396 screws were placed accurately (87.96%). Procedural errors led to combined payouts totaling $124,943,933 in neurosurgery claims between 2003 and 2012 in a study looking at data from the Physician Insurers Association of America Data Sharing Project.10 However, our study is the first to report the direct medicolegal impact of screw misplacement on US spine surgery, with 30.9% of judgments/settlements in favor of the plaintiff, resulting in average payouts of $1,204,422 $753,832 per claim. Can Postoperative Radiographs Accurately Identify Screw Misplacements? Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. 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). 2019;19(7):12211231. 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. 2012 Feb 1;37(3):E188-94. Conclusion: This patient recovered completely in 6 weeks. 5. 2021 Jul 1;41(Suppl 1):S80-S86. Introduction. J Pediatr Orthop. A retrospective review of closed medicolegal cases with verdicts or settlements between 1995 and 2019 was performed using the Westlaw Edge legal research database (Thomson Reuters).7,14,16,23,24 A search of closed federal and state malpractice claims within the Verdicts and Settlements section consisted of the following: spine and surgery and pedicle and screw and fusion and (misplaced or misguided or mispositioned) and surgeon. Inclusion criteria consisted of malpractice claims against surgeons for complications related to misplaced pedicle and/or lateral mass screws. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. 17. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. J Bone Joint Surg 62A:13021307, 1980. None of these complications resulted in additional surgery or in a significant increase of morbidity. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. Pedicle screw fixation is commonly used in spinal instrumentation surgeries to connect rods to vertebrae in order to correct spine alignment, stabilize vertebrae, and reach an arthrodesis. 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. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. 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). 2005;293(21):26092617. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. It has a great developing technique that is used for fixation and fusion in spine surgery. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Analysis and interpretation of data: Sankey, TT Than. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. 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. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. A misplacement rate of more than 20 % (129 misplaced screws out of 608) seems to be unacceptable compared to only 4.5 % misplacements when using CT-navigation leading to the conclusion that pedicle screw instrumentation in the middle and upper thoracic area should be carried out with the help of navigation only. Spine 13:952953, 1988. Administrative/technical/material support: Mehta, Wang, KD Than. Problems of balance were coronal (scoliosis greater than 5 or trunk shift greater than 5 mm) as seen on the AP radiograph taken with the patient standing or sagittal (failure to obtain or maintain lumbar lordosis). Whitecloud et al 35 reported an overall 45% rate of minor and major complications, with the rate of complications increasing to 63% in patients who had previous lumbar surgery. Drafting the article: Sankey. 30. J Neurosurg Spine. We attribute the 24.1% disc space narrowing in the instrumented segments mainly to the severe injury of the disc and communication of the end plate in burst fractures, which could accelerate the disc degeneration and narrowing. 2011;365(7):629636. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). I won't be at the office but I will check my voice mail. 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. Moffatt-Bruce SD, Ferdinand FD, Fann JI. Your current browser may not support copying via this button. Thankfully, most screws are just misplaced by a millimeter or two out the front or are slightly off medially, so they are not doing real damage. 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. MeSH 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. 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. Taylor CL. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Orthop Trans 11:99, 1987. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Over 40% of patients had screws with either some/major concern. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. 2012;37(1):6776. J Am Coll Surg. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. 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). Acta Neurochir (Wien). 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. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. J Spinal Disord Tech. Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. 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. Plaintiff-awarded cases by US region (left). leg pain. Fager CA. 2022 Sep 15;14(9):6323-6331. eCollection 2022. Despite commonly used, questions remain about their safety especially for the thoracic spine and in deformity where difficulty in positioning can lead to pedicle breach and adjacent structures injury. Similarly, the highest inflation-adjusted amount awarded ($2,302,472) for pseudarthrosis was attributed to a medially breached pedicle screw during an L5S1 fusion that was determined to have caused the failed union and subsequent need for revision surgery. 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 . 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. Balch CM, Oreskovich MR, Dyrbye LN, et al. Spine 19:25842589, 1994. PMC Acquisition of data: Sankey. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. 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. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. 3. 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. 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. Forty-seven general complications were seen in 41 patients (36.5%). 2016;102(2):358362. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Rajasekaran S, Bhushan M, Aiyer S, et al. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. Elizabeth Hofheinz, M.P.H., M.Ed. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. 11. Surg Neurol. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. The states with the most cases included California (n = 10, 14.7%), New York (n = 6, 8.8%), Pennsylvania (n = 6, 8.8%), and Illinois (n = 5, 7.3%; Table 2). States were then grouped by US region and case year by 5-year intervals. The rate of medical complications was 8%. 3). Several limitations should be carefully considered when interpreting our results. 2018;43(14):984990. Spine 16:576579, 1991. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. Hardware-related failures were observed in 12 patients (10.7%). In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. 2014;20(6):636643. 2014;75(6):609613. The third patient, who had central spinal stenosis, was treated by decompression alone. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. 2014;96(4):266270. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. 2018;18(2):209215. Clin Orthop 115:130139, 1976. 2017;27(4):470475. NCI CPTC Antibody Characterization Program. Segal J. 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. JAMA. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. 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. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. Spine 19(20 Suppl):2279S2296, 1994. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. Data is temporarily unavailable. Insuring spinal neurosurgery. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). These numbers are in line with the current literature. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. (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. 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. 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). 16. 8,24,25,32. It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. Clin Orthop 203:7598, 1986. 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. 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. Accessibility 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. Spine 6:615619, 1981. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. doi: 10.1097/BPO.0000000000001828. 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. Spine J. Quraishi NA, Hammett TC, Todd DB, et al. 2020;162(6):13791387. Moreover, several cases stated that the surgeon used only the anteroposterior or the lateral view, but not both, and the plaintiffs counsel used this information in support of their claim. This study has shown that percutaneous insertion of pedicle screws in the lumbar spine is a safe and reliable technique, and despite the low misplacement rate of only 6.6%, it should be kept in mind that the surgical procedure is technically demanding and should be performed only by experienced spine surgeons. 2012;7(6):e39237. 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. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. 14. 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. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. Results. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. 38. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. Operative information including fusion level, number of levels fused, level of misplaced screw(s), single versus multiple misplaced screw(s), presence of known CSF leakage, and primary injury due to screw misplacement was also collected.