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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S7 SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S7 SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9734056
Device Problem Imprecision (1307)
Patient Problems Tissue Damage (2104); Complaint, Ill-Defined (2331)
Event Date 10/18/2018
Event Type  Injury  
Manufacturer Narrative
No devices were returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used intra/peri-operatively of a cervical spine procedure. It was noted by the representative that this event was not due to an alleged product issue, but the report was made just in case. A follow-up will be conducted to confirm this event. It was reported that imaging system and navigation were used along with the articulating arm and a tracker. When performing an insertion of ps on the right side of c4, it was confirmed by navigation that the screw was inserted without any problems. However, when confirming with the imaging system after the insertion, it was suspected that the screw deviated to the lateral side and caudal side. Va got an injury, and it was unknown if there were symptoms occurred to the root of c5. Revision of the screw was required and the screw was removed and used at another position after removal. The posterior fusion procedure of the c2-th1. Both imaging and navigation systems were used. The reference was set in the c2, insertion was made in order from the top. After the c5 screw was inserted, the frame moved and was re-shot in the middle of inserting left c5 screw. At the moment, the pedicle screw of the right c4 was confirmed to deviate toward outside and caudal side. The screw was removed and skipped. There was no bleeding, but injury might occur to vertebral artery or nerve root. The use of navigation was continued without problem after c5. The patient impact is not known.
 
Manufacturer Narrative
Patient information was unavailable from the site. Refused by dr. (b)(6). Additional information added. Has been updated for c50773. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was confirmed that the screw on the right side of c4 deviated, but the screw was removed to be placed at another vertebral body. It was also noted that the procedure was a posterior cervical fusion. There was no delay to the procedure and there was no abnormality in the post-operative process.
 
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Brand NameNAVIGATION STEALTH STATION S7 SYSTEM
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8081338
MDR Text Key127531543
Report Number1723170-2018-05701
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734056
Device Catalogue Number9734056
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/02/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/16/2018 Patient Sequence Number: 1
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