MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
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Model Number UNK_OARM_SYS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscle Weakness (1967); Unspecified Nervous System Problem (4426)
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Event Date 05/17/2021 |
Event Type
malfunction
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Event Description
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Mao, g., elhamdani, s., gigliotti, m.J., mace, a., sclabassi, r., oh, m., whiting, d.Neurologic complications in monitored versus unmonitored image-guidance assisted posterior lumbar instrumentation.World neurosurg.2021.152 (e155-e160) https://doi.Org/10.101 6/j.Wneu.2021.05.074 background: intraoperative neurophysiologic monitoring (iom) has been used clinically since the 1970s and is a reliable tool for detecting impending neurologic compromise.However, there are mixed data as to whether long-term neurologic outcomes are improved with its use.We investigated whether iom used in conjunction with image guidance produces different patient outcomes than with image guidance alone.Methods: we reviewed 163 consecutive cases between january 2015 and december 2018 and compared patients undergoing posterior lumbar instrumentation with image guidance using and not using multimodal iom.Monitored and unmonitored surgeries were performed by the same surgeons, ruling out variability in intersurgeon technique.Surgical and neurologic complication rates were compared between these 2 cohorts.Results: a total of 163 patients were selected (110 in the nonmonitored cohort vs.53 in the iom cohort).Nineteen signal changes were noted.Only 3 of the 19 patients with signal changes had associated neurologic deficits postoperatively (positive predictive value 15.7%).There were 5 neurologic deficits that were observed in the nonmonitored cohort and 8 deficits observed in the monitored cohort.Transient neurologic deficit was significantly higher in the monitored cohort per case (p: 0.0198) and per screw (p: 0.0238); however, there was no difference observed between the 2 cohorts when considering permanent neurologic morbidity per case (p: 0.441) and per screw (p: 0.459).Conclusions: the addition of iom to cases using image guidance does not appear to decrease long-term postoperative neurologic morbidity and may have a reduced diagnostic role given availability of intraoperative image-guidance systems.Reported events: 1 patient exhibited worsening preexisting lower-extremity weakness, 5 patients exhibited new motor deficits, and 2 patients experienced only sensory deficits.All 5 cases of neurologic deficit in the nonmonitored group presented with new-onset motor weakness postoperatively with 3 of the 5 cases showing complete symptomatic resolution at follow-up in total, 16 patients experienced emg burst activities and 5 patients experienced temg changes 7 patients experienced emg irritation stratified for patients with abnormal signals at baseline before surgery, 5 patients experienced emg irritation see attached literature article.
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Manufacturer Narrative
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Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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