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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9731780
Device Problems Unstable (1667); Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/16/2016
Event Type  malfunction  
Manufacturer Narrative
The site declined to provide patient information, per (b)(4) privacy laws. Return requested for suspect open spine clamp. No parts have been received by manufacturer for analysis. No further issues have been reported.
 
Event Description
A medtronic representative received a report that, while in a spine procedure, the surgeon was unable to securely attach the spine clamp to the spinous process. A second referencing set was opened, allowing the surgeon to continue the procedure. Delay in therapy was 4 minutes. The surgeon completed the procedure with the use of the navigation system. There was no impact on patient outcome.
 
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Brand NameOPEN SPINE CLAMP, TITANIUM
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
judith ericson
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key5498804
MDR Text Key40302823
Report Number1723170-2016-00346
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K990214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 03/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9731780
Device Lot Number121219
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 Received02/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2012
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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