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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9734715
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/09/2018
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
Medtronic received information regarding a navigation device instrument being used outside of a procedure.It was reported that there was a damaged spine clamp.It would not close and the screw would spin, but not engage.There was no patient present when this issue was identified.No further information was provided.
 
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Brand Name
CLAMP, SPINOUS PROCESS TALL
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key7476517
Report Number1723170-2018-01817
Device Sequence Number16657428
Product Code OLO
UDI-Device Identifier00643169936300
UDI-Public00643169936300
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K131425
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 05/01/2018
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 Number9734715
Device Lot Number170425
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/09/2018
Initial Report FDA Received Date05/01/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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