Medtronic received information regarding a navigation system.It was reported that the patient had an estimated blood loss of 2000ml and confirmed 4 packed red blood units given.Apparent procedure was related to an adverse event.There were no further complications reported regarding the event.Additional information was received stating that medtronic would assess as causal relationship to study procedure, not related to study device.On (b)(6) 2024, spinal procedure at levels l4-l5, l5-l6 and l5-s1; staged surgery; open access.Allograft used.Total estimated blood loss 50 ml.On (b)(6) 2024 spinal surgery at levels l3-l4, l4-l5 and l5-s1.Open access.39 screws were placed during surgery.Infuse bmp used.Total estimated blood loss 2000 ml.
|
H3,h6) no parts have been received by the manufacturer for evaluation.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.
|