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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SPINE REFERENCE CLAMP; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SPINE REFERENCE CLAMP; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9733037
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/18/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.
 
Event or Problem Description
A medtronic representative reported that, while in a procedure, the spine clamp being used could be tightened but could not be loosened.There was no reported impact on patient outcome.No additional information was provided.
 
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Brand Name
SPINE REFERENCE CLAMP
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key6794293
Report Number1723170-2017-03333
Device Sequence Number1736068
Product Code HAW
UDI-Device Identifier00613994233738
UDI-Public00613994233738
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K050438
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 08/15/2017
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
Operator of Device Physician
Device Catalogue Number9733037
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/18/2017
Initial Report FDA Received Date08/15/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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