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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 Unstable (1667); Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 02/01/2016
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Device lot number not available. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. (b)(4) 2016 a medtronic representative, following-up at the site, reported speaking with the doctor. The surgeon reported that the open spine clamp did not broke rapidly, in one moment, it got worse and worse over time until the moment when he decided it should be replaced. The surgeon stated surgery was performed normally to the last day. (b)(4) 2016 further details from the medtronic representative confirm the hexagon joint between the driver and the clamp became more round. The surgeon stated that the place where he inserts the driver to tighten the screw became more loose and he would have to put more effort into tightening the screws. Return requested for open spine clamp; no parts have been received by manufacturer for analysis.
 
Event Description
A site physician reported an open spine clamp that had a broken thread. No further details regarding the damage, or how it occurred, were provided. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Correction to suspect medical device. Further review of the returned components found that the driver was the cause of the reported event. Brand name, catalog # and lot #, and concomitant medical product and therapy dates were updated to reflect the findings below. Medtronic investigation of returned suspect driver finds that the returned driver is very worn. The tip of the driver is rounded out making it difficult to engage the head of the clamp. The reported event was confirmed to be caused by a mechanical failure mode. 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. Medtronic investigation of returned suspect clamp finds that the returned clamp was found to be in good condition. There is no damage to the threads of the adjustment screw. The clamp is fully functional.
 
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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 Key5461193
MDR Text Key39086315
Report Number1723170-2016-00254
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K990214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9730027
Device Lot Number091010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2010
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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