Product analysis : deformation of the handle bolt and the deformation of the fix ring and the fix nut were confirmed.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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Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having microscopic lum bar posterior decompression for lumbar spinal stenosis.It was reported that the upper arm was tightened to achieve adhesion, but sufficient adhesion force could not be obtained. the upper arm was tightened, but it did not provide sufficient fixation force, so it moved.When the upper arm was loosened in order to adjust its position, it did not move at all because the joint was hard.There was no patient symptom reported.There were no further complications reported regarding the event.
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