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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 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. No parts have been received by manufacturer for analysis.
 
Event Description
A medtronic representative reported that, while preparing for an upcoming procedure, the site found their open spine clamp was worn. No further details regarding the damage were provided. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Correction - device unique device identifier (udi) now provided. Device lot number now provided. Investigation of returned suspect clamp finds that the returned clamp is well worn. Several teeth on the clamp are bent. There is debris in the threads of the adjustment screw. The head of the screw has tool marks around it. The retainer ring on the tip of the adjustment screw is stretched allowing some play in the movement of the clamp face. The reported issue was confirmed to be caused by mechanical failure due to wear. 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.
 
Manufacturer Narrative
Mfg 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
catherine eaton
826 coal creek circle
louisville, CO 80027-9710
7208902092
MDR Report Key6138104
MDR Text Key61238950
Report Number1723170-2016-05615
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,Followup
Report Date 02/08/2017
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 Number9731780
Device Lot Number5110111095
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 Received01/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2005
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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