pedicle screw misplacement malpractice

5-7 Materials and Methods This is a retrospective study of kyphotic spondylitis tuberculosis (Stb) patients conducted at Fatmawati General Hospital, Jakarta, Indonesia, through the year 2020-2021. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). I won't be at the office but I will check my voice mail. 2022 Sep 15;14(9):6323-6331. eCollection 2022. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. J Neurosurg Spine. Both of these patients complained of thigh pain but refused any additional surgery. Spine J. Orthop Trans 11:99, 1987. The plaintiff underwent revision surgery in May 2013. 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. Dr. Abd-El-Barr is a consultant for Spineology. Nayar G, Blizzard DJ, Wang TY, et al. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). J Neurosurg Spine. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. A total of 2724 screws were placed in 127 patients. The pedicle screws judged as misplacement. a Medial minor perforation J Neurosurg Spine. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. 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As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. 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 ]. 6 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. JAMA. Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. You are talking one of the most complicated area of the law. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. Spine 15:1114, 1990. 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%. Clin Orthop 203:7598, 1986. 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. Privacy Policy. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. Unable to load your collection due to an error, Unable to load your delegates due to an error. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. 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). 2006;65(4):416421. The rate of reoperation for screw misplacement per screw was 0.17%. 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. Hecht N, Kamphuis M, Czabanka M, et al. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. All case demographics are summarized in Table 1. 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. Malpractice claims in spine surgery in Germany: a 5-year analysis. 1. 3. The highly litigious environment within healthcare has resulted in a majority of physicians practicing defensive medicine,15 often leading to burnout6,7 and an exorbitant ethical and financial burden on medical and surgical care.7,8 In 2008, medical liability accounted for $55.6 billion, representing 2.4% of the United States (US) healthcare expenditures that year,5,7,9,10 and the pervasive practice of defensive medicine may cost up to $210 billion annually in the US.5 A similar trend has been observed in Europe.11, Neurosurgery is the specialty most frequently affected by lawsuits and the fear of litigation, both in the US and abroad,12 with spine surgery at the forefront.11,1317 As a result, spine surgeons are nearly three times more likely than nonspine surgeons to practice defensive medicine, defined as the avoidance of high-risk procedures and the provision of unnecessary services and assessments beyond what is clinically necessary in an effort to avoid litagation.5 The average time to judgment in a case is approximately 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 As a result, physicians spend an average of 11% of their careers dealing with one or more open malpractice claims.18 Neurosurgeons are especially impacted, spending an average of 27.2% of their careers in an open lawsuit.10. 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. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. The patient had to undergo a subsequent surgery to remove the pedicles. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Linking and Reprinting Policy. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. 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? West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. 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. Summary of background data: 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. Drs. 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). Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. The link was not copied. 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. One hundred four of the 112 patients had a posterior procedure. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. 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 (Phila Pa 1976). 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. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. 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. General complications were considered those developing during and after surgery that were not directly related to instrumentation. 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). What can spine surgeons do to improve patient care and avoid medical negligence suits? 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. 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. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. 39. For more information, please refer to our Privacy Policy. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. Friedlander and Bradley will pay half of the $2.25 million. Weinstein JN, Spratt KF, Spengler D, Brick C, Reid S: Spinal pedicle fixation: Reliability and validity of roentgenogram-based assessment and surgical factors on successful screw placement. 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. Malpositioned pedicle screw resulting | Legal Advice - LawGuru Show more. Health Aff (Millwood). 29. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. 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. Elizabeth Hofheinz, M.P.H., M.Ed. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement Presse Med 78:14471448, 1970. Malpractice issues in neurological surgery. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. Acta Neurochir (Wien). 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. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. Thus, meaningful efforts to limit the rate of misplaced pedicle and lateral mass screws, such as the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation, should be carefully considered. Hardware problems were those related to the physical change of metal and screw position. 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. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. Methods. Critically revising the article: all authors. 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). Defensive medicine in U.S. spine neurosurgery. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. 2013;32(1):111119. Insuring spinal neurosurgery. 2012;7(6):e39237. A total of 69 patients (mean age, 67.416 . Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. 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. Retrospective Computed Tomography Scan Analysis of Percutaneously In six patients (5.3%) with degenerative spine disease, the disc material had been removed. Introduction. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. single homes for sale in lehigh valley, pa A total of 2396 screws were placed accurately (87.96%). Level of evidence: Pullout performance comparison of pedicle screws based on cement Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. Spine J. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). Each side was judged separately. Li HM, Zhang RJ, Shen CL. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. Thoracic Pedicle Screws - ScienceDirect Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. Segal J. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. Comparison of pedicle screw placement accuracy between two types of Spine 17:834837, 1992. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Each case was then carefully screened for relevance and sufficient data. Spine 18:11601172, 1993. 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. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. Defendant-awarded cases by US region (right). 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. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. 5. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? PMC 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. Can Postoperative Radiographs Accurately Identify Screw Misplacements? Objective: HHS Vulnerability Disclosure, Help This site needs JavaScript to work properly. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. Are We Underestimating the Significance of Pedicle Screw Misplacement Epstein NE. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. Pedicle screw insertion techniques: an update and review of the Ahmadi SA, Sadat H, Scheufler KM, et al. An official website of the United States government. Pedicle screw replacement in spinal surgery - The MDU 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. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Median screw misplacement rate was 10% in group A and 13% in group B. Data is temporarily unavailable. Spine 18:23252326, 1993. 2012 Feb 1;37(3):E188-94. 30. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. Spine (Phila Pa 1976). 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. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. Neurological outcome and management of pedicle screws - PubMed 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. Seven hundred sixty-three screws were inserted in 138 patients. 1. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. Would you like email updates of new search results? However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. 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. 2011;365(7):629636. Call me tomorrow. To investigate intraoperative reinsertion of percutaneous pedicle screw (PPS) with intraoperative CT-based navigation and to evaluate the rate of deviation of PPS at postoperative radiographic examination. 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). Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Patient-specific 3D-printed surgical guides for pedicle screw insertion 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. 21. 6. Svider PF, Kovalerchik O, Mauro AC, et al. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. Malpractice risk according to physician specialty. Delayed open treatment of aortic penetration by a thoracic pedicle 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%). Over 40% of patients had screws with either some/major concern. Percentage of cases per US region (center). 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). All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years.

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pedicle screw misplacement malpractice