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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SOLERA SCREWDRIVER INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC SOLERA SCREWDRIVER INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9734856
Device Problem Degraded (1153)
Patient Problem No Patient Involvement (2645)
Event Date 05/26/2020
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. The screwdriver was returned to the manufacture for evaluation. After visual/physical examination the reported issue was confirmed. The tip of the driver was twisted and bent. The manufacture date was not available at the time of reporting. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that the driver was worn. There was no patient present when this issue was identified.
 
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Brand NameSOLERA SCREWDRIVER
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10254473
MDR Text Key198385114
Report Number1723170-2020-01891
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
Type of Report Initial
Report Date 07/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734856
Device Catalogue Number9734856
Device Lot Number140107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
Was Device Evaluated by Manufacturer? Yes
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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