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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK II UNIVERSAL TRACKER, LARGE CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK II UNIVERSAL TRACKER, LARGE CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 961-580
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/18/2017
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.
 
Event or Problem Description
A site representative reported that, while outside of a procedure, the screw head of the clamp was stripped.The reported issue resulted in the clamp being unusable as the driver could not fit onto the top.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, LARGE CLAMP
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key6643374
Report Number1723170-2017-02497
Device Sequence Number11089318
Product Code OLO
UDI-Device Identifier00721902467691
UDI-Public00721902467691
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) 06/15/2017
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 Number961-580
Device Lot Number151106
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/18/2017
Initial Report FDA Received Date06/15/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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