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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2016
Event Type  malfunction  
Manufacturer Narrative
On 11/22/2016 a medtronic representative performed a navigation system check-out, software and instruments areas passed. Hardware test failed. The medtronic representative stated that many scans with oarm and s7 on different setting were performed and found zero inaccuracies. System performed as intended. On 11/22/2016 a medtronic representative in attendance at the procedure, reported that in all, this took 5 minutes to determine why the surgeon deemed being inaccurate. After placing the taps, the surgeon did not navigate the screws, however, often times the surgeon does not do this out of habit. During this procedure, we used all medtronic devices. The surgeon alleged being "off by less than a millimeter" when the medtronic representative checked on accuracy today using the navigation system, imaging system and assorted devices i. E. Navlocks. Reported issue could not be replicated. Accuracy was ¿dead-on¿. The medtronic representative utilized every frame and took many different spins to analyze any possible involvement. On 12/05/2016 software analysis was unable to determine probable cause with the information provided. Reported issue could not be replicated. - no further issues have been reported.
 
Event Description
A medtronic representative reported that, while in a spinal fusion procedure, the surgeon alleged an inaccuracy occurred. The surgeon deemed being inaccurate based on "rescue screws" placed (these are non-medtronic rescue screws from previous technology at this site). The rescue screws appeared to be less than a millimeter too superior on the sagittal plane traj 2 and similarly on the traj 1 view. The surgeon made holes in the pedicles (l4&5) using navigation, however, decided against using navigation for the screws. The surgeon opted to complete the procedure without the use of the navigation system. There was no delay of therapy. There was no impact on patient outcome.
 
Manufacturer Narrative
Correction: per a conference call with the fda on 23-jan-2017, the fda requested a supplemental 3500a submission regarding clarification to the manufacturer associated with the previously reported non-medtronic device involved with the incident. The non-medtronic device was reported to be manufactured by stryker.
 
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Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
amos jarrette
826 coal creek circle
louisville, CO 80027-9710
7208902082
MDR Report Key6158332
MDR Text Key61895210
Report Number1723170-2016-05682
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 01/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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