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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 08/24/2017
Event Type  Injury  
Manufacturer Narrative
Correction: unique device identification (udi) updated to proper value. This device is included in medical device field correction notification, "difficulty in opening and removing spinous process clamps" (june 2017). The revised instructions for use (ifu) were provided with the notification.
 
Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations. No parts have been received by the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that, while in a spinal fusion, the washer on the spine clamp came off. The representative reported that the spine clamp could not be removed from the spinous process. In order to remove the clamp, a piece of the spinous process was removed. There was a reported delay to the procedure of less than 1 hour due to 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
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key6884614
MDR Text Key102614351
Report Number1723170-2017-03749
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K131425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Remedial Action Notification
Type of Report Initial,Followup
Report Date 10/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9734715
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberFCA 2017-06-22

Patient Treatment Data
Date Received: 09/21/2017 Patient Sequence Number: 1
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