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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 Bent (1059); Fracture (1260); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/05/2009
Event Type  malfunction  
Manufacturer Narrative
Site declined to provide patient demographic information.05/04/2009 medtronic spinal & biologics division analysis of suspect part: the instrument was returned for evaluation.Visual examination found that the reversing axis is broken in the middle.The superior jaw presents a small lateral bending, as well as the tip of the binding screw.Breakage appears to be due to an over-torque of the binding screw.The bending of the different components may have occurred during tightening or may have been present before use.No corrective action is required at this time - the fault is attributed to improper use.A review of the complaint history found no additional information to add to this investigation.No parts have been received by manufacturer for analysis - discarded.No further issues have been reported.
 
Event Description
A medtronic representative reported that, while in a spine procedure, the handling unit of the tightening screw on their open spine clamp was broken during use.No further details regarding the damage, or when in the procedure it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.
 
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Brand Name
OPEN SPINE CLAMP, TITANIUM
Type of Device
NEUROLOGICAL 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 Key5498591
MDR Text Key40259688
Report Number1723170-2016-00234
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,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 03/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number9731780
Device Lot Number080222
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/05/2009
Initial Date FDA Received03/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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