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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, THORACIC, RADIOLUCENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, THORACIC, RADIOLUCENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9733148
Medical Device Problem Codes Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/17/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.
 
Event or Problem Description
A site representative reported that, while outside of a procedure, the adjustment screw head was worn on the clamp.There was no patient present when this issue was identified.No additional information was provided.
 
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Brand Name
CLAMP, THORACIC, RADIOLUCENT
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key7259929
Report Number1723170-2018-00618
Device Sequence Number13702498
Product Code HAW
UDI-Device Identifier00613994201263
UDI-Public00613994201263
Combination Product (Y/N)N
Initial Reporter CountrySE
PMA/510(K) Number
K990214
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 02/09/2018
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 Number9733148
Device Lot Number161010
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/17/2018
Initial Report FDA Received Date02/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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