Model Number TPL0059 |
Device Problems
Computer Software Problem (1112); Imprecision (1307)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/17/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
A medtronic representative went to the site to test the equipment.Testing revealed that system passed all testing and was working as intended.Analysis of the software exports and logs found the complaint was confirmed.After reviewing all available information, analysis concluded the probable cause of the medial deviations of left and right t6 to be an anatomy shift.As t7 was fractured, the segment above it was unstable, and further fixation was required.Medial skiving potential along the cortical slope was a contributing factor.The use of the midas drill could not eliminate the skiving potential as the segment was mobile, with even a slight force to lead to a deviation.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.
|
|
Event Description
|
Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that the guidance system was used during a fracture trauma case.Three days later, a revision was done to revise two breached screws at t6.The left and right t6 screws were 2 mm medial to plan.A c-arm was used to remove and place the screws at t6.During the initial procedure, the surgical system was mounted to the patient using a spinous process clamp placed at t9 and the bone mount bridge.T7 was too unstable for the clamp due to the fracture and the surgeon did not want to use t8 since they thought the clamp would be in the way of the trajectory.A ct to fluoro workflow was used and screws were placed at left t6 and left t8.The surgeon then switched to the right side.No neuromonitoring was done to test motor function due to the patient's airway (tracheostomy tube in place).The surgeon questioned accuracy during the case and a 10 point accuracy test was successfully completed.Navigation was accurate when checked with the passive planar being placed on the spinous process and the divot on the arm guide.The surgeon was on trajectory with the tap, screw, and dilator, but believed that with the new software updates, there was a glitch with the drill.The tracker had to be rotated to get the trajectory perfect and required more manipulation than other trackers.The surgeon also noted that they had to place slight pressure on the arm to get the drill trajectory to match up.The surgeon controlled for soft tissue pressure during the procedure.The procedure was delayed less than an hour.
|
|
Manufacturer Narrative
|
Section e was corrected.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.
|
|
Search Alerts/Recalls
|
|