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
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A1-a5) patient information was unavailable from the site.B3) event date is the online publishing date of the literature article.D4) device lot number, or serial number, unavailable.G4) 510(k) is dependent upon the device model number and therefore, unavailable.H3,h6) no parts have been received by the manufacturer for evaluation.H4) 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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Event Description
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Stone, l., mcdonald, m., wojdyla, l., osorio, j.A.Integrating navigation assistance for redirecting freehanded spinal instrumentation: experience and technique.Journal of robotic surgery (2023) 17:2729¿2734 https://doi.Org/10.1007/s11701-023-01686-9 abstract retrospective review of all spinal fusions > 3 levels involving the thoracolumbar and/or sacroiliac at a single institution, by a single surgeon between 3/12/2020 and 8/13/2021 were reviewed.All screws that were secondarily navigated after identified as misdirected on intraoperative ct scan were included.Neuromonitoring reports were culled for ma threshold to triggered emg response for all redirected screws.Intraoperative, post-de novo screw placement images (fluoroscopy scout and intraop-erative ct) and post-redirection intraoperative scoliosis films and post-operative scoliosis films were independently reviewed by a senior neuroradiologist.Fifty redirected screws in the thoracic, lumbar, sacral, and ilium were identified as misdirected and redirected via navigation.The new trajectory of all screws was confirmed satisfactory by independent review between a senior neuroradiologist and neurosurgeon.Four screws could not be verified by post-operative imaging (4/50, 8%).All triggered emg stimulated > 15 ma.No screws required return to the operating room for revision.No patients experienced a post-operative deficit.Redirection of misdirected thoracolumbar and sacroiliac screws can be performed using intraoperative ct and navigation as a means to detect and directly visualize appropriate placement.Reported events: misdirected screws were classified as follows: 13 medial, 18 lateral, 4 inferior, 3 superior, 3 long, 2 inferolateral, 1 superolateral.See attached literature article.
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Search Alerts/Recalls
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