pedicle screw misplacement malpractice

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Dr. Friedlander did not order a CT or MRI until January 2013, when the pedicle screw was found to be in the wrong location and a failed fusion was diagnosed, according to the suit. Each case was then carefully screened for relevance and sufficient data. 1. 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. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. 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. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. 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. Deyo RA, Mirza SK, Martin BI. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. 2012;37(1):6776. Both issues represent the most frequent and highest payouts in spine malpractice claims.10,14,22 While several studies have explored many of the factors related to malpractice claims in spine surgery, the medicolegal impact of misplaced pedicle and/or lateral mass screws has not been directly reported in the literature. Spine (Phila Pa 1976). Clin Orthop 203:4553, 1986. 5. 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). 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. The intent is to provide relief from pain and nerve damage. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. 2018;41(5):e615e620. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Spine 6:615619, 1981. 2020;11:38. Spine 17:349355, 1992. Pedicle screw placement accuracy impact and comparison between grading NCI CPTC Antibody Characterization Program. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Orthopedics. 2018;43(14):984990. Clin Orthop 284:8090, 1992. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. 2018;83(5):9971006. Pedicle screw placement is a common procedure. 2012;7(6):e39237. 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. Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. In White AH, Rothman RH, Ray CD (eds). Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. 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. All the operations were done by one surgeon (PK). Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. The .gov means its official. Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. 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. The link was not copied. J Neurosurg Spine. Of note, the award amount for one settlement case was undisclosed. were excluded from analysis. The third patient, who had central spinal stenosis, was treated by decompression alone. 8,24,25,32. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. 2011;24(1):1519. 2014;75(6):609613. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. Federal government websites often end in .gov or .mil. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. Spine 19:25842589, 1994. 3. government site. 1. 17. Clin Orthop 203:717, 1986. Furthermore, 25 patients (22.3%) reported persistent pain in the iliac crest (donor graft site) for several months, for which they were treated with repeated lidocaine injections and analgesics. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. Balch CM, Oreskovich MR, Dyrbye LN, et al. A total of 69 patients (mean age, 67.416 . A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. 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. Nayar G, Blizzard DJ, Wang TY, et al. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. Notwithstanding these concessions, the MDU argued that misplacement of pedicle screw tracts was common in surgery of this kind, even in experienced and competent hands. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Bookshelf An official website of the United States government. Retrospective Computed Tomography Scan Analysis of Percutaneously The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. With pedicle shapes and sizes varying wildly in the scoliotic spine, misplacement of a screwas well as and under- or oversizingare real possibilities in spine surgery. Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). 36. J Spine Surg. 2014;21(3):320328. 2018;18(2):209215. 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. Neurological outcome and management of pedicle screws - PubMed Daniels AH, Ruttiman R, Eltorai AEM, et al. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. This patient recovered completely in 6 weeks. The screws were needed to stabilize the spine and fix the fused vertebrae in place. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 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. The cost of defensive medicine on 3 hospital medicine services. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. The rate of reoperation for screw misplacement per screw was 0.17%. Plaintiff-awarded cases by US region (left). 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. To prevent general complications, it is evident that precise and careful soft tissue handling, proper irrigation, and debridement during and after surgery, decrease of operative time, and proper patient monitoring postoperatively must be done. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. Call me tomorrow. Epub 2021 Aug 28. 2018;27(9):23392347. 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. Defensive medicine: a culprit in spiking healthcare costs. 11. Patient-specific 3D-printed surgical guides for pedicle screw insertion Objective: Each side was judged separately. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). A rod is used to hold the vertebra together to allow fusion to occur. Results: 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 . doi: 10.1097/BRS.0b013e31822a2e0a. 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). Rajaee SS, Bae HW, Kanim LE, Delamarter RB. Call Us Now For a Free Consultation | Toll Free: 800.583.8002 | Local: 312.346.0045, Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants , Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation , Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in, $75 Million Jury Verdict in Failure to Timely Diagnose Stroke, $18 Million Jury Verdict in Late Diagnosis of Breast Cancer, $300,000 Settlement for Excessive Use of Radiation, Chicago Medical Malpractice Lawyer Kreisman Law Offices Home, Contact Illinois Personal Injury Attorney Kreisman Law Offices. Two-dimensional (2D) fluoroscopy-guided percutaneous pedicle screw (PPS) placement is currently the most widely applied instrumentation for minimally invasive treatment of spinal injuries requiring stabilization. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. All the incidental dural tears were repaired immediately and produced no clinical sequelae. 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. Complications and Problems Related to Pedicle Screw Fixation - LWW Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. J Neurosurg. Moffatt-Bruce SD, Ferdinand FD, Fann JI. 2011;306(10):1088. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. Dr. Shaffrey has received grants from the NIH and Department of Defense. Spine (Phila Pa 1976). 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. 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. Methods. Careers. Potential complications may include increased pain, infection, or mechanical . A total of 2396 screws were placed accurately (87.96%). Defensive medicine in neurosurgery: the Canadian experience. Bydon M, Xu R, Amin AG, et al. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Spine 13:696706, 1988. J Neurosurg Spine. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. J Spinal Disord Tech. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. Re: malpositioned pedicle screw resulting in additional surgery and disability. Some error has occurred while processing your request. Hecht N, Kamphuis M, Czabanka M, et al. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Defensive medicine in U.S. spine neurosurgery. 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). Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. Ann Thorac Surg. Patient safety: disclosure of medical errors and risk mitigation. 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. Jena AB, Seabury S, Lakdawalla D, Chandra A. Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted A.J. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . 3. JAMA Intern Med. 2022 Sep 15;14(9):6323-6331. eCollection 2022. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. 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. Mason A, Paulsen R, Babuska JM, et al. Spinal fusion procedures are increasingly performed each year, with Deyo et al. single homes for sale in lehigh valley, pa McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Per-patient analysis reveals more concerning numbers toward screw misplacement. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. South Med J 62:17, 1969. N Engl J Med. 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. Lumbar Spine Surgery. Health Aff (Millwood). Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. Spine 18:983991, 1993. Study design: 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. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. leg pain. Pedicle screw insertion - AO Foundation However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. your express consent.

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