pedicle screw misplacement malpractice

22. 1. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Deyo RA, Mirza SK, Martin BI. Please enable scripts and reload this page. Orthop Trans 11:99, 1987. Clin Orthop 115:130139, 1976. Several limitations should be carefully considered when interpreting our results. 2018;29(4):397406. 2020;11:38. 2014;21(3):320328. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. Balch CM, Oreskovich MR, Dyrbye LN, et al. What can spine surgeons do to improve patient care and avoid medical negligence suits? 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. to maintaining your privacy and will not share your personal information without 7. A total of 2724 screws were placed in 127 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. Dr. Goodwin has received grants from the Burroughs Wellcome Fund, North Carolina Spine Society, and Robert Wood Johnson Harold Amos Medical Faculty Development Program and the NIH/NINDS K12 NRCDP Physician Scientist Award. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. Harrington and Tullos 11 first reported the technique of transpedicle screw fixation, and Roy-Camille et al 23 popularized the first practical method of pedicle screw fixation. 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. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). 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. These numbers are in line with the current literature. Neurosurgery. 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. However, the highest offer had been a combined $300,000 from the two defendants. 21. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. 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. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). 18. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. Spine 16:576579, 1991. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. Mason A, Paulsen R, Babuska JM, et al. Please try again soon. 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. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. J Spinal Disord Tech. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Med Econ. 34. J Neurosurg. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. doi: 10.1097/BRS.0b013e31822a2e0a. A p < 0.05 was considered statistically significant. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. A high-low agreement is a settlement in which a defendant agrees to pay the plaintiff a minimum recovery in exchange for the plaintiff agreeing to accept a maximum amount regardless of the trial's outcome. This was followed by pseudarthrosis requiring revision surgery, present in 14.3% (n = 3) and 14.9% (n = 7) of plaintiff- and defendant-awarded cases, respectively (p = 0.99). Under this theory of liability, the plaintiff needed to not only establish that she had experienced foot drop, a fact that no one was disputing, but that it was caused by the defendants negligence. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. You are talking one of the most complicated area of the law. General complications were considered those developing during and after surgery that were not directly related to instrumentation. West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. 2. However, the misplacement of pedicle screws can lead to disastrous complications. 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. Spine J. Spine (Phila Pa 1976). 2012;89(10):7071. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. Call me tomorrow. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. Eur Spine J. 2014;20(2):196203. The contact form sends information by non-encrypted email, which is not secure. Elizabeth Hofheinz, M.P.H., M.Ed. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Autor de la entrada Por ; Fecha de la entrada austin brown musician; matrix toners for bleached hair . The defendants explanation provided an explanation for why Nyquists foot drop did not resolve after the misplaced screw was removed and shed doubt on the plaintiffs theory of liability. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. Spine 17:349355, 1992. 2014;96(4):266270. In order to prove medical malpractice occurred, the plaintiffs attorney needs to show not only the plaintiff experienced a poor medical outcome, but that it was directly caused by medical negligence. Data is temporarily unavailable. 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. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Spine 18:11601172, 1993. An official website of the United States government. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. Clin Orthop 203:126134, 1986. J Neurosurg Spine. Spinal fusion procedures are increasingly performed each year, with Deyo et al. Epub 2014 Jun 13. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. 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. and transmitted securely. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. 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. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. 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. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. Clin Orthop 203:717, 1986. 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. A total of 2396 screws were placed accurately (87.96%). Spine (Phila Pa 1976). Am J Orthop. 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. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Smith TR, Hulou MM, Yan SC, et al. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. Spine 18:18621866, 1993. Daniels AH, Ruttiman R, Eltorai AEM, et al. Malpractice litigation following spine surgery. In our opinion, these problems may be prevented by applying the following principles: limitation of spine arthrodesis to the pathologic levels, inclusion of already extensive changes at the level above or below the planned arthrodesis into the arthrodesis, restoration of postoperative sagittal and coronal alignment, and avoidance of impingement syndrome from the adjacent nonfused facets. Spine 13:10121018, 1988. 1. Malpractice issues in neurological surgery. One hundred four of the 112 patients had a posterior procedure. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. Over 40% of patients had screws with either some/major concern. Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. 3. 2011;306(10):1088. There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). In their meta-analysis of nine randomized controlled trials, Li et al. Am J Otolaryngol. Preparation. Both of these patients complained of thigh pain but refused any additional surgery. Malpractice claims in spine surgery in Germany: a 5-year analysis. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Spine 16(8 Suppl):S455458, 1991. 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. Don't jump in get legal help. Federal government websites often end in .gov or .mil. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. 2005;293(21):26092617. Malpractice liability and defensive medicine: a national survey of neurosurgeons. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. PMC It is indicated that screws medially misplaced at a distance greater than 2-mm, especially 4 mm, may be a cause of negative effects on the neural structure and should be removed during the early phase of the postoperative period, even among patients without postoperative neurological abnormalities. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. Likewise, research shows that breaches still occur when these tools are used,33,40 and some studies did not find a difference in pedicle breach rates compared to those with traditional fluoroscopic and freehand techniques.33 Ultimately, misplaced instrumentation is a risk of any spinal fusion surgery, and a thorough discussion of these risks, as well as the alternative management options, is essential to maintain high-quality patient care and to avoid litigation. Pedicle screw placement is a common procedure. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. government site. 2011;24(1):1519. 2. 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). shooting in valdosta leaves one dead sharing sensitive information, make sure youre on a federal Statistical analysis: Sankey. J Bone Joint Surg 54A:11951204, 1972. 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. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. J Neurosurg Spine. N Engl J Med. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. 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). matte black square deadbolt; roberts point park fishing report; qr code on binax covid test; mff premium character list. Clin Orthop 203:7598, 1986. JAMA Intern Med. 2017;42(3):177185. Spine (Phila Pa 1976). Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. Clinical Orthopaedics and Related Research411:86-94, June 2003. your express consent. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. Results. 1. HHS Vulnerability Disclosure, Help However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. Defensive medicine: a culprit in spiking healthcare costs. 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 . All Rights Reserved. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. J Neurosurg Spine. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). Analysis and interpretation of data: Sankey, TT Than. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? 2013;32(1):111119. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. The remaining eight patients, including two patients with spinal trauma, five patients with infection, and one patient with a tumor, had anterior and posterior procedures. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. This site needs JavaScript to work properly. J Neurosurg Spine. Insuring spinal neurosurgery. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. Spine 24:23522357, 1999. Neurosurgery. Accessibility 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. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. 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. 12. 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. In the Kane County medical malpractice lawsuit of Melissa Nyquist v. Dr. Taras Masnyk and DuPage Neurosurgery, S.C., 06 L 421, the plaintiffs attorney was unable to convince the jury that the plaintiffs medical complications were caused by the defendants negligence. Each side was judged separately. J Neurosurg Spine. Studdert DM, Mello MM, Sage WM, et al. 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. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. 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. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. Roy-Camille R, Roy-Camille M, Demeulenaere C: Osteosynthese du rachis dorsal, lombaire et lombo-sacre par plaque metalliques vissees dans les pedicules vertebraux et es apophyses articularies. Personal consequences of malpractice lawsuits on American surgeons. 3. 2018;41(5):e615e620. Nevertheless, research has shown that screws are misplaced in approximately 14%55% of cases using the standard techniques (freehand and 2D fluoroscopic guidance) employed by most spine surgeons,21,33 resulting in injury in approximately 1%8% of cases.21 In addition to the avoidable procedural risk to the patient, each misplaced screw carries the threat of future litigation, as reported above. J Bone Joint Surg 61A:201207, 1979. 2018;43(14):984990. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. 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. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. What can spine surgeons do to improve patient care and avoid medical negligence suits? Health Aff (Millwood). The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. 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. 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. However, this is the first study to evaluate the direct medicolegal impact of misplaced pedicle and lateral mass screws on spine surgery in the US and presents important information that may support the routine use of intraoperative imaging confirmation (via 3D fluoroscopy or intraoperative CT) and/or navigated screw placement (either computer- or robot-assisted) as a potential method to decrease the risk of future litigation during spinal fusion procedures.

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