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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS TALL ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS TALL ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9734715
Device Problem Material Deformation (2976)
Patient Problems Spinal Column Injury (2081); Iatrogenic Source (2498)
Event Date 01/03/2018
Event Type  Injury  
Manufacturer Narrative
Part udi is now provided in appropriate field. Part manufacture date is now provided in appropriate field. Analysis of the returned reported clamp confirmed physical damage as the retainer ring was pulled from the tip of the adjustment screw and was missing. As is, the adjustment screw would be able to close the clamp but not open it. 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
Udi not available for this system at time of filing. Device manufacturing date is not available at this time. No parts have returned to the manufacturer for evaluation. Part not returned for analysis.
 
Event Description
A site representative reported that, while in a spinal fusion procedure the spine clamp was damaged and broke. The physician had to remove the spinous process due to the damaged clamp. At that point, the physician aborted imaging and navigation and used a c-arm to successfully complete the case. There was an approximate 10 minute delay to the procedure as a result of this issue. No additional information was provided.
 
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Brand NameCLAMP, SPINOUS PROCESS TALL
Type of DeviceORTHOPEDIC 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
sam saleh
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7215779
MDR Text Key102629672
Report Number1723170-2018-00316
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9734715
Device Lot Number150123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/24/2018 Patient Sequence Number: 1
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