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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 Material Deformation (2976); Naturally Worn (2988)
Patient Problem No Patient Involvement (2645)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
Device manufacturing date is dependent on lot number therefore, unavailable. Return requested. No parts have been received by manufacturer for analysis. No further issues have been reported.
 
Event Description
A medtronic representative reported a damaged spine instrument. It was reported to be stripped over continuous use over time. No further details regarding the damage, or specifically how it occurred, were provided. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Device lot number now provided. Device manufacturing date now provided.
 
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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
kristianna bilan
826 coal creek circle
louisville, CO 80027
7208902338
MDR Report Key6210068
MDR Text Key63427605
Report Number1723170-2016-05949
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 company representative,health
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 01/25/2017
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 Number9731780
Device Lot Number130729
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 Received12/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2013
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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