pedicle screw misplacement malpractice

Pedicle screw fixation is commonly used in spinal instrumentation surgeries to connect rods to vertebrae in order to correct spine alignment, stabilize vertebrae, and reach an arthrodesis. The patient had to undergo a subsequent surgery to remove the pedicles. 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. In their meta-analysis of nine randomized controlled trials, Li et al. Both of these patients complained of thigh pain but refused any additional surgery. J Neurosurg Spine. Per-patient analysis reveals more concerning numbers toward screw misplacement. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. Defendant-awarded cases by US region (right). 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. 2002;27(22):24252430. shooting in valdosta leaves one dead 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. . 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. 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. However, the highest offer had been a combined $300,000 from the two defendants. There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). 2019;19(7):12211231. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. 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. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. 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). Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. 3). 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. J Neurosurg Spine. 7. 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. Spine 18:11601172, 1993. This occurred on only one side and the correction achieved by the instrumentation was maintained. Bookshelf Statistical analysis: Sankey. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. Your current browser may not support copying via this button. Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. While the majority of claims are found to lack merit, resulting in a verdict in favor of the defendant or case dismissal,7,1316 at least 37% are considered valid.26 Regardless, payouts to plaintiffs are often substantial, averaging in the hundreds of thousands to millions of dollars in both the US and Europe.10,11,14,17,20 Communication of errors and expectations, thorough documentation, and selection of appropriate patients and surgical indications have been shown to reduce the likelihood of a successful malpractice claim.13,16,27,28 In addition, attempts at tort reform in some states have helped limit the financial burden of medical malpractice payouts through methods such as capitation.16,20,22,26 However, efforts to limit malpractice claims in the first place are greatly needed. 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. Spine 19(20 Suppl):2279S2296, 1994. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. 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. 4. 15. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. 12. Clin Orthop 115:130139, 1976. It has a great developing technique that is used for fixation and fusion in spine surgery. The average age of the patients was 47 years and the average followup was 35 months. 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). Ahmadi SA, Sadat H, Scheufler KM, et al. Spine 16(8 Suppl):S422427, 1991. 2021 Jul 1;41(Suppl 1):S80-S86. Spine 24:23522357, 1999. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. 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. What can spine surgeons do to improve patient care and avoid medical negligence suits? Under the high-low agreement, Drs. 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. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of 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. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). Presse Med 78:14471448, 1970. Careers. 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. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. J Bone Joint Surg 54A:11951204, 1972. You may be trying to access this site from a secured browser on the server. Spine (Phila Pa 1976). 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. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. 2020;11:38. 2011;24(1):1519. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. In addition, studies have shown that over 85% of malpractice claims are either dismissed or settled out of court,14 which likely results in a high degree of underreporting. Level of evidence: 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). The physician ordered an MRI of the lumbar spine which showed that the screws had been misplaced and were puncturing the patient's lumbar nerves. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. 32. Bydon M, Xu R, Amin AG, et al. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Each side was judged separately. EOS System Courtesy of EOS imaging. Studies have shown that the greatest proportion of malpractice claims in spine surgery are related to procedural error,10,11,14,16,17,19 often resulting in the highest payouts.11,20 For spine surgery, one common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass screws, which occurs in approximately 14%55% of cases using standard techniques and results in neurological injury and/or durotomy in approximately 1%8% of cases.21 Misplaced screws have the potential to cause severe and sometimes permanent neurological deficits, including spinal cord and/or nerve root injury,21 as well as to decrease the stability of the fusion construct, leading to delayed complications related to pseudarthrosis. Scarone P, Vincenzo G, Distefano D, et al. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. Spine 18:23252326, 1993. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. 2018;27(9):23392347. 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. Drafting the article: Sankey. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. 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. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. 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. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. your express consent. Eur Spine J. 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. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. Don't jump in get legal help. Balch CM, Oreskovich MR, Dyrbye LN, et al. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. 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. Please enable it to take advantage of the complete set of features! Image intensification and the technique recommended by Weinstein et al 32 was used for screw placement in the lumbar vertebrae, whereas Chopin blocks (Medtronic Sofamor Danek) with two screws diverging bilaterally were used for sacral fixation. The initial search using the terms above returned 3654 cases. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. 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. Acquisition of data: Sankey. 2014;20(6):636643. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. 2013;32(1):111119. Am J Otolaryngol. 2017;42(3):177185. 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. Conclusion: Spine J. 2014;20(2):196203. Nahed BV, Babu MA, Smith TR, Heary RF. Fortunately, most of the complications were minor and transient. Epstein NE. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. 2014;75(6):609613. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. MeSH Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. Intraoperative pedicle fractures requiring further points of fixation. 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. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. This site needs JavaScript to work properly. In the other patient, L4L5 float arthrodesis was done. Characteristics of medicolegal cases related to misplaced screws in spine surgery. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Neurosurgery. J Neurosurg Spine. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. 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. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. Rothberg MB, Class J, Bishop TF, et al. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. (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. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Li HM, Zhang RJ, Shen CL. Accessibility Study design: Am J Transl Res. 10. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. Spine 6:263267, 1981. J Neurosurg Spine. 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). 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. Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. Critically revising the article: all authors. Instead, the defense offered up an alternative explanation for Nyquists foot drop.

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