MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
|
Back to Search Results |
|
Model Number 9735665 |
Device Problem
Imprecision (1307)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/17/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Concomitant medical products: other relevant device(s) are: product id: 9735740, serial/lot #: (b)(4).Software logs have been returned to the manufacturer and are pending analysis.(b)(4).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.
|
|
Event Description
|
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure.It was reported that there was an alleged inaccuracy.During a case, the frame was accidentally bumped.The medtronic representative (rep) strongly suggested that the surgeon perform another spin to re-register the patient.However, the surgeon rejected another spin since they decided to verify the accuracy by using a landmark on the patient's pelvis.They determined the accuracy to be acceptable and continued with the surgery.The rep pointed out that the patient was larger, and did not have visible landmarks that would suffice as a valid accuracy verification.After all six screws were inserted, they did a post-op scan with the imaging system to verify placement of the screws but found them all to be inaccurate.The rep reported that the s1 screws were off by at least 1 cm, and that the other screws were also off but not by as much.The surgeon took another spin and replaced all six screws.The surgeon continued using navigation to place the six in their correct trajectories.The delay of the case was 45 minutes and there was no reported impact on patient outcome.The rep stated that she was absolutely certain that the inaccuracy was due to the bumping of the frame.The rep performed three test spins on her model and found that all three spins produced accurately navigable exams.The resolution was confirmed on the call.
|
|
Manufacturer Narrative
|
H3: a software analysis was initiated.However, it was found that the suspected cause was that the frame was bumped.Based on the information provided, the issue does not appear to be a software related issue.H6: b01, c19 and d14 apply to the software analysis.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
|
|
|