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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 961-576
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/29/2017
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 site representative reported that, while outside of a procedure, the screws on the clamp were worn.There was no patient present when this issue was identified.No additional information was provided.
 
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Brand Name
SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key6661270
Report Number1723170-2017-02620
Device Sequence Number1615543
Product Code OLO
UDI-Device Identifier00721902467738
UDI-Public00721902467738
Combination Product (Y/N)N
PMA/510(K) Number
K983670
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) 06/22/2017
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 Number961-576
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/29/2017
Initial Report FDA Received Date06/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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