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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) OPEN SPINE CLAMP DRIVER NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) OPEN SPINE CLAMP DRIVER NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9730027
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. No parts have been received by the manufacturer for evaluation.
 
Event Description
A site representative reported that the bit 015-1016 drill 1mm x 16mm is damaged. It is not known how it was damaged. No patient was present during the time of the reported incident.
 
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Brand NameOPEN SPINE CLAMP DRIVER
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
jasmine birlew
826 coal creek circle
louisville, CO 80027
MDR Report Key6210794
MDR Text Key63475029
Report Number1723170-2016-05952
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 12/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9730027
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2016
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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