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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS SHORT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9734716
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Spinal Column Injury (2081)
Event Date 06/05/2018
Event Type  Injury  
Manufacturer Narrative
Device lot number, and unique device identification (udi), unavailable. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. No evaluation has been performed as there was no allegation of deficiency against a medtronic product. No allegation of deficiency.
 
Event Description
Medtronic received information that, while in a spinal fusion, the spinous process was damaged when utilizing the spine clamp. It was noted that a portion of the process was broken off. It was reported that the issue occurred prior to the first image acquisition and that the site moved the clamp 1 level to complete the procedure. It was noted that the clamp was tightened excessively, resulting in the reported issue. 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 SHORT
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
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7656762
MDR Text Key112989855
Report Number1723170-2018-03094
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
Reporter Occupation
Type of Report Initial
Report Date 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number9734716
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/02/2018 Patient Sequence Number: 1
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