Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. All case demographics are summarized in Table 1. leg pain. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. $2 Million Spinal Surgery Case Against Neurosurgeon and Hospital FOIA 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. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. 2014;20(2):196203. 3). Spine 17:834837, 1992. A total of 2724 screws were placed in 127 patients. However, only a few complications were related to a poor clinical outcome. 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). 13. These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. Malpractice litigation following spine surgery. 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. 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). When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. 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. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. 10. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. 2 One of the first obstacles regarding . 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. sharing sensitive information, make sure youre on a federal A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Drs. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. 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. Can Postoperative Radiographs Accurately Identify Screw Misplacements? Importantly, these advanced technologies are not always readily available or the standard of care and cannot supplant a thorough understanding of operative anatomy, a high-quality surgical technique, and general complication-avoidance measures. Unauthorized use of these marks is strictly prohibited. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. The rate of misplaced pedicle screws ranges from 1.1% to 28.8%, 10 although neurologic injury from misdirected pedicle screws has been reported to occur in 0% to 12% of patients. Retrospective Computed Tomography Scan Analysis of Percutaneously J Bone Joint Surg 73A:11791184, 1991. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. Rovit RL, Simon AS, Drew J, et al. 2019;19(7):12211231. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. Patient-specific 3D-printed surgical guides for pedicle screw insertion Legal liability in iatrogenic orbital injury. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. 20 Tips to Avoid and Handle Problems in the Placement - ScienceDirect Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. Agarwal N, Gupta R, Agarwal P, et al. One hundred twelve consecutive patients were entered into a retrospective study of instrumented thoracolumbar, lumbar, and lumbosacral spinal arthrodesis at our institution, between September 1994 and January 1999. Thus, in the current study we aimed to describe this impact in the US, as well as to suggest a potential method for mitigating the problem. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt Taylor CL. 26. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. 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. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? 6 Bydon M, Xu R, Amin AG, et al. St Louis, CV Mosby 322327, 1987. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Over 40% of patients had screws with either some/major concern. Most of these complications were minor and with the exception of two misplaced screws, did not contribute to the occurrence of neurologic impairment or severe pain. The median time to case closure was longer for defendant-awarded cases, but this finding was not statistically significant (61.5 vs 56.3 months, p > 0.05). All Rights Reserved. The https:// ensures that you are connecting to the Am J Orthop. 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. 2020;45(2):E111E119. Screw misplacement. 25. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. It has a great developing technique that is used for fixation and fusion in spine surgery. All Rights Reserved. Balch CM, Oreskovich MR, Dyrbye LN, et al. 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. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. 2014;21(3):320328. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. A total of 2396 screws were placed accurately (87.96%). 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. Don't jump in get legal help. To reinforce spinal fixation, we have proposed a construct with segmental pedicle fixation two levels above and one level below the injured level and insertion of a screw deep into the pedicle, providing more contact area between screw head and bone and reducing the moment arm of the bending stress. 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. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. 144 2021 Jul 1;41(Suppl 1):S80-S86. 2007;106(6):11081114. Clin Orthop 227:1023, 1988. 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. J Neurosurg Spine. 30. Jena AB, Seabury S, Lakdawalla D, Chandra A. J Am Coll Surg. 2018;83(5):9971006. 2. Pedicle Screw Malposition Expert Witness: Malposition Can Lead to 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). A p < 0.05 was considered statistically significant. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. 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. 4). government site. 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%). J Neurosurg Spine. Intraoperative pedicle fractures requiring further points of fixation. 2011;24(1):1519. Nayar G, Blizzard DJ, Wang TY, et al. The cost of defensive medicine on 3 hospital medicine services. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. 37. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) Before Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. 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. 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. (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. Br J Neurosurg. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. 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 ]. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). doi: 10.1097/BRS.0b013e31822a2e0a. 2020;11:38. Ann R Coll Surg Engl. 2011;306(10):1088. Show more. In the current series, including general complications, only 48 patients (43%) had no notable complication and the remaining 64 patients (57%) had one or more complications. 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. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. Hardware-related failures were observed in 12 patients (10.7%). 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). 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. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. Critically revising the article: all authors. Clin Orthop 284:8090, 1992. 2. Spine (Phila Pa 1976). Nottmeier EW, Seemer W, Young PM. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. The cost of defensive medicine on 3 hospital medicine services, Defensive medicine in neurosurgery: the Canadian experience, Review of neurosurgery medical professional liability claims in the United States, A nine-year review of medicolegal claims in neurosurgery, Malpractice risk according to physician specialty, Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003, Descriptive analysis of state and federal spine surgery malpractice litigation in the United States, Malpractice litigation following spine surgery, Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis, Malpractice claims in spine surgery in Germany: a 5-year analysis, On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim, Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England, Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort, It is easier to confuse a jury than convince a judge: the crisis in medical malpractice, Determining legal responsibility in otolaryngology: a review of 44 trials since 2008, Legal liability in iatrogenic orbital injury, Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study, Malpractice issues in neurological surgery. Copyright © 2023 Becker's Healthcare. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. Rynecki ND, Coban D, Gantz O, et al. 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 . Introduction. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. 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. Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. 15. NCI CPTC Antibody Characterization Program. The rate of reoperation for screw misplacement per screw was 0.17%. Patient safety: disclosure of medical errors and risk mitigation. Epub 2014 Apr 4. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. JAMA Intern Med. 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). Unable to load your collection due to an error, Unable to load your delegates due to an error. 2018;41(5):e615e620. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Defensive medicine in U.S. spine neurosurgery. Although pedicle screw fixation opened a new horizon of spinal surgery by providing rigid fixation of the spine, it is a technically demanding procedure with potential complications including medical complications, hardware and technical problems, and long-term changes of junctional motion segments. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. 39. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. 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. Scarone P, Vincenzo G, Distefano D, et al. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. Ultimately, additional prospective, multiinstitutional large-volume studies are needed to validate these findings, and future studies should evaluate the long-term impact on the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation on the frequency and success of malpractice claims related to misplaced pedicle and lateral mass screws. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. One hundred four of the 112 patients had a posterior procedure. 1). Friedlander and Bradley will pay half of the $2.25 million. 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%). Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). Spine (Phila Pa 1976). Spine 24:23522357, 1999. J Neurosurg. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. laterally placed screws and the azygous vein on the right (T5-T11). West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. 9. None of these complications resulted in additional surgery or in a significant increase of morbidity. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. 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. Surg Neurol. Median screw misplacement rate was 10% in group A and 13% in group B. 12. 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? Spine 8:970981, 1996. 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. 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. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. 2012;21(suppl 2):S196S199. Dr. Abd-El-Barr is a consultant for Spineology. You are talking one of the most complicated area of the law. 32. Pedicle screw insertion in the thoracolumbar spine. Thoracic Pedicle Screws - ScienceDirect Level of evidence: Potential complications may include increased pain, infection, or mechanical . reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. 33. 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. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). 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). 0 attorneys agreed. 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. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. Spine 14:472476, 1989. Zdeblick 38 also reported an overall arthrodesis rate of 65% in patients without instrumentation, 77% in patients with semirigid fixation, and 95% in patients with a rigid constrained screw-rod system. 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. J Bone Joint Surg 62A:13021307, 1980. Pedicle screw placement is a common procedure. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. Instead, the defense offered up an alternative explanation for Nyquists foot drop. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. 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. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Conclusion: Pullout strength of misplaced pedicle screws in the thoracic and lumbar 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. J Neurosurg Spine. 38. Spinal fusion in the United States: analysis of trends from 1998 to 2008. True accuracy of percutaneous pedicle screw placement in thoracic and 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. 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The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. 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. Lumbosacral pedicle screw placement using a fluoroscopic pedicle axis Spine 13:952953, 1988. 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. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. Clinical Orthopaedics and Related Research411:86-94, June 2003. The pedicle screw system is widely used in spine surgery, and it provides rigid fixation and leads to successful subsequent deformity correction and bony fusion. L3S1 spine arthrodesis was done in the first patient but the correction of scoliosis was not sufficient and coronal imbalance persisted after surgery, which accelerated the degeneration of the level just above the arthrodesis. MeSH Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. Mississippi Appellate Court Affirms Medical Malpractice Defense Verdict Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). This site needs JavaScript to work properly. Complications and Problems Related to Pedicle Screw Fixation - LWW
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