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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 Codes Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/03/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.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 in a spinal fusion, the threads on a spine clamp were damaged and the clamp could not function.No additional information was provided.There was no reported delay to the procedure due to this issue.There was no reported impact on patient outcome.
 
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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 Key6446460
Report Number1723170-2017-01399
Device Sequence Number682014
Product Code OLO
UDI-Device Identifier00721902467691
UDI-Public00721902467691
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K983670
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 03/30/2017
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
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/03/2017
Initial Report FDA Received Date03/30/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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