Model Number TPL0038 |
Device Problems
Imprecision (1307); Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/08/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The main component of the system.Other relevant device(s) are: product id: asm0113, a medtronic representative went to the site to test the equipment.The rbt device was replaced.The system then passed the system checkout and was found to be fully functional.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 almost all of the trajectories were off during a l4-s1 alif procedure.The amount of deviation was unknown, but the manufacture representative estimated they were 3.5-10 mm.The representative noted that the drill bit was engaged in bone, but the reduction tube was breaking out anterior and lateral.Several different patient registrations were done, but the issue was not resolved.The rbt device initially passed the three point setup test, but after running a stress test the device failed on point 19 of 27.The rbt device was able to be used for five screws.The surgeon decided to abort the use of the guidance system and freehand the last trajectory.The cause of the deviation was suspected to be the rbt device or a possible shift in registration; however, the deviation was consistent after several registrations.The surgeon took all measures to ensure platform stability, avoid soft tissue pressure, burr the docking surface and use proper cannula technique.There was no patient harm and the procedure was extended two hours.
|
|
Manufacturer Narrative
|
H3: analysis of the rbt device found the complaint was confirmed.Visual/physical examination and functional testing found the device was out of calibration.The rbt device was repaired, recalibrated and passed all testing.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
|
|