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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURETRAK II UNIVERSAL TRACKER, LARGE CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC SURETRAK II UNIVERSAL TRACKER, LARGE CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 961-580
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/15/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that the large clamp was damaged; the large clamp had a stripped screw.There was no patient present when this issue was identified.
 
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Brand Name
SURETRAK II UNIVERSAL TRACKER, LARGE CLAMP
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key8420538
Report Number1723170-2019-01110
Device Sequence Number2242052
Product Code OLO
UDI-Device Identifier00721902467691
UDI-Public00721902467691
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K983670
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/14/2019
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 Health Professional
Device Model Number961-580
Device Catalogue Number961-580
Device Lot Number180219
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/15/2019
Initial Report FDA Received Date03/14/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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