pedicle screw misplacement malpractice30 Mar pedicle screw misplacement malpractice

20 Tips to Avoid and Handle Problems in the Placement - ScienceDirect Pedicle screw insertion techniques: an update and review of the Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. 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). Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. Am J Transl Res. 2. Your message has been successfully sent to your colleague. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Accuracy of pedicle screw insertion by AIRO intraoperative CT in complex spinal deformity assessed by a new classification based on technical complexity of screw insertion. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. 7. Reoperation for Misplaced Pedicle Screws: A Multicenter Retrospec 2012;7(6):e39237. MeSH Lumbar Spine Surgery. A rod is used to hold the vertebra together to allow fusion to occur. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. Background The objective of this cadaveric study was to analyze the effects of iatrogenic pedicle perforations from screw misplacement on the mean pullout strength of lower thoracic and lumbar pedicle screws. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. J Neurosurg Spine. A p < 0.05 was considered statistically significant. Pedicle screw placement: Robotic assistance for greater precision The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. Patient safety: disclosure of medical errors and risk mitigation. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. Neurologic injury. Spine (Phila Pa 1976). The rate of reoperation for screw misplacement per screw was 0.17%. NCI CPTC Antibody Characterization Program. The authors of the current study aimed to describe this impact in the United States, as well as to suggest a potential method for mitigating the problem. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 6. One hundred four of the 112 patients had a posterior procedure. Spine 18:23252326, 1993. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. Epub 2014 Apr 4. J Pediatr Orthop. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. 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%). J Neurosurg. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. 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 ]. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. However, only a few complications were related to a poor clinical outcome. 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Hardware-related failures were observed in 12 patients (10.7%). Are We Underestimating the Significance of Pedicle Screw Misplacement As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. Laryngoscope. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. It argued that the foot drop was unavoidable and due to the surgeons need to manipulate the right L5 nerve root in order to remove Nyquists herniated disc during the spinal fusion surgery. Forty-seven general complications were seen in 41 patients (36.5%). The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. 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. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. Spine 17:349355, 1992. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. 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. Acquisition of data: Sankey. 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. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. 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. 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. Segal J. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. haroinfather roblox id Schatlo B, Molliqaj G, Cuvinciuc V, et al. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. Pedicle screws are used by spine surgeons as part of a fusion in which two adjacent bones in the spine are combined together as one. 2014;20(2):196203. You are talking one of the most complicated area of the law. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. 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? 2020;45(2):E111E119. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. 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. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. All case demographics are summarized in Table 1. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. (A) Anteroposterior and (B) lateral radiographs taken 1 year after surgery show upper screw breakage in the application of a short Cotrel-Dubousset construct in a T12 burst fracture. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. The screws were needed to stabilize the spine and fix the fused vertebrae in place. (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. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. 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. Delayed open treatment of aortic penetration by a thoracic pedicle Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. PLoS One. 2016;102(2):358362. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. Administrative/technical/material support: Mehta, Wang, KD Than. Categorical and continuous data are described as frequency (percentage) and median (interquartile range), respectively, except for the use of mean standard deviation for award amounts since both nominal and inflation-adjusted award totals passed (alpha = 0.05) the DAgostino-Pearson omnibus normality test. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Pitfall: Unstable injuries. Clin Orthop 203:4553, 1986. 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. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. Review of neurosurgery medical professional liability claims in the United States. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. J Bone Joint Surg 61A:201207, 1979. We also investigated the effect of bone mineral density (BMD), diameter of pedicle screws, and the region of spine on the pullout strength of pedicle screws. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. Accuracy of C2 pedicle screw placement using the anatomic freehand Arthrodesis was questionable in eight asymptomatic patients (7.1%). Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). 2020;162(6):13791387. Thu, May 27th, 2021. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. Objective: 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. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. Spine Deform. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. CT-navigation versus fluoroscopy-guided placement of pedicle screws at Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. 2011;365(7):629636. Epstein NE. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. 2018;18(2):209215. Comparison of pedicle screw placement accuracy between two types of The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. What can spine surgeons do to improve patient care and avoid medical negligence suits? 8600 Rockville Pike 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. An official website of the United States government. Although the rationale for using pedicle screw fixation is fairly clear, controversy continues regarding the application of pedicle instrumentation for spine arthrodesis, especially on the degenerative lumbar spine. 2012;21(suppl 2):S196S199. Introduction. 2018;43(14):984990. Spine 17:834837, 1992. The radiology results showed that the surgical screw placed at the right L4-5 area had breached the medial wall and was actually extending into the spinal canal. 2014;96(4):266270. The initial search using the terms above returned 3654 cases. 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. The largest inflation-adjusted payout awarded to the plaintiff ($3,372,185) for nerve root injury occurred in a 36-year-old male who had undergone an L4S1 posterior spinal fusion, which resulted in permanent and direct injury to right L5 and S1 nerve roots, with foot drop and radiculopathy. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. Study design: Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. Spine 18:983991, 1993. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. 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. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. Spine (Phila Pa 1976). Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. A total of 2396 screws were placed accurately (87.96%). 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). Surg Neurol. * 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. 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. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Dr. Abd-El-Barr is a consultant for Spineology. 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 medicolegal landscape of spine surgery: how do surgeons fare? Of note, the award amount for one settlement case was undisclosed. Intraoperative pedicle fractures requiring further points of fixation. J Am Coll Surg. Percentage of cases per US region (center). 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. South Med J 62:17, 1969. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). 2 One of the first obstacles regarding . 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. 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. Both of these patients complained of thigh pain but refused any additional surgery. 3). The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. $2 Million Spinal Surgery Case Against Neurosurgeon and Hospital Rajaee SS, Bae HW, Kanim LE, Delamarter RB. 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). While reported to be one of the best legal research resources available and utilized in several previous studies,7,14,16,23,24 available court documents and clinical/operative details are highly variable and greatly limited among case files. 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. The site is secure. 2021 Jul 1;41(Suppl 1):S80-S86. The average followup was 35 months (range, 1851 months). . To prevent the development of pseudarthrosis, we think it is important for surgeons to apply the following five technical principles: the proper-sized pedicle screw has to be inserted on the first attempt; repeated manipulation in setting instruments must be avoided; anterior penetration of the screw into the sacrum and insertion of two screws in each side are advocated for fixing the lumbosacral junction; industrious and detailed decortication of the posterior elements must be developed fully; and the use of autologous bone graft is recommended. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. Steffee AD, Brantigan JW: The variable screw placement spinal fixation system: Report of a prospective study of 250 patients enrolled in Food and Drug Administration clinical trials. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Luque ER: Segmental spinal instrumentation of lumbar spine. Please try again soon. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. J Neurosurg Spine. 26. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. 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. Spine (Phila Pa 1976). Better strategies need to be devised for evaluation of screw placement, including establishment of a national database of deformity surgery, use of intra-operative image guidance, and reevaluation of postoperative low-dose CT imaging. 2018;28(2):186193. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. J Neurosurg Spine. 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. Under the high-low agreement, Drs. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Studdert DM, Mello MM, Sage WM, et al. Pedicle Screw Malposition Expert Witness: Malposition Can Lead to Health Aff (Millwood). Neurological Outcome and Management of Pedicle Screws Misplaced Totally 2011;213(5):657667. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 2009;10(1):3339. A retrospective review of charts, XRs and low-dose CT scans of 127 patients who underwent spinal fusion with pedicle screws for spinal deformity was performed. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw.

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