Model Number TPL0059 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/03/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H3, h6) the system was serviced in the field and the complaint was not verified.The system performed as intended and no faults were found.Codes b01, c19, and d14 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that after performing registration and receiving green indication of the planned trajectory within the software, the navigation of the instrument when the arm was sent to the l3 planned trajectory appeared to be inferiorly deviated from the target by 5 millimeters (mm).After re-registering the patient and re-segmenting the scans, the issue was resolved and no further issue arose during the procedure.There was no impact to patient's outcome.
|
|
Manufacturer Narrative
|
See b5.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Additional information received from a manufacturer representative reported that the procedure was not delayed.
|
|
Search Alerts/Recalls
|
|