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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INST KIT SPINE CLAMP; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INST KIT SPINE CLAMP; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9735129
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/12/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.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.
 
Event or Problem Description
A medtronic representative reported that, while outside of a procedure, the screw on the spine clamp was stripped.There was no patient present when this issue was identified.No additional information was provided.
 
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Brand Name
INST KIT SPINE CLAMP
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key7393976
Report Number1723170-2018-01414
Device Sequence Number11116919
Product Code HAW
UDI-Device Identifier00643169308879
UDI-Public00643169308879
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K001153
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) 04/03/2018
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 Number9735129
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/12/2018
Initial Report FDA Received Date04/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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