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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) UNIVERSAL DRILL GUIDE NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) UNIVERSAL DRILL GUIDE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 960-521
Device Problem Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Device lot number, or serial number, unavailable. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. No parts have been received by the manufacturer for evaluation. Part not returned for analysis.
 
Event Description
A medtronic representative reported that, while outside of a procedure, the universal drill guide would not tighten sufficiently. It was noted that the internal portion for the screw was stripped. There was no patient present when this issue was identified. No additional information was provided.
 
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Brand NameUNIVERSAL DRILL GUIDE
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
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7102686
MDR Text Key94411634
Report Number1723170-2017-05053
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00673978089904
UDI-Public00673978089904
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number960-521
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 Received11/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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