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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 Problems Material Deformation (2976); Naturally Worn (2988)
Patient Problem No Patient Involvement (2645)
Event Date 11/07/2016
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Device lot number, or serial number, not available. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. Return requested for suspect open spine clamp driver. No parts have been received by manufacturer for analysis. Part not received by manufacturer.
 
Event Description
A medtronic representative reported that, while preparing for an upcoming procedure, the site found their open spine clamp driver was worn. No further details regarding the damage were provided. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Investigation of returned suspect driver finds that the returned driver is well worn. The handle is discolored and the part and lot numbers are illegible. The tip of the driver is slightly rounded out but still usable. The reported issue was confirmed to be caused by a mechanical failure due to wear of the driver tip. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
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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
kristianna bilan
826 coal creek circle
louisville, CO 80027-9710
7208902338
MDR Report Key6138125
MDR Text Key61237618
Report Number1723170-2016-05616
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 12/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9730027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2016
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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