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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC NAVLOCK TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9736061
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2020
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site.Device manufacturing date, unknown.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 during a revision case where they were adding l2 and l5 to an existing construct, there were issues tracking the blue and black navlocks and the robotic reference frame.They were tracking intermittently.The representative had the spheres replaced and verified they were snapped into place.There was no line of site issues.The representative moved or lights away as well.When the instrument was tracked it was showing up in the middle of the near/far tracking range under tracking details.The representative checked the geometry error and it was resting at.35 -.45 when the instrument was facing the camera straight on.No patient harm was reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative reported that they did determine that the problem was not with the reference frame or any of the navlocks but rather was caused by interference from the surgeons camera headlight.When the surgeon stared at the surgeon tablet, they found that the instruments and reference frame would disappear from the tracking view, however, when he looked away, they would reappear.The problem only occurred when using that particular headlight.Since the issue was determined to not reside with the devices, they have not been returned for analysis.
 
Manufacturer Narrative
H2) additional information: patient information updated 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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Brand Name
NAVLOCK TRACKER
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key9700351
MDR Text Key183882609
Report Number1723170-2020-00481
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K182104
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9736061
Device Catalogue Number9736061
Was Device Available for Evaluation? No
Date Manufacturer Received03/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age69 YR
Patient Weight87
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