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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC S7; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734715
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/19/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Foreign country: (b)(6).No parts have been received by the manufacturer for evaluation.The manufacture date not available at the time of reporting.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 outside of a procedure that the spine clamp will not open or close.No patient was present at the time of the event.
 
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Brand Name
S7
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key8718181
Report Number1723170-2019-03659
Device Sequence Number13971447
Product Code OLO
UDI-Device Identifier00643169936300
UDI-Public00643169936300
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K131425
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/20/2019
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 No Information
Device Model Number9734715
Device Catalogue Number9734715
Device Lot Number160707
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/19/2017
Initial Report FDA Received Date06/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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