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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PERCUTANEOUS REFERENCE CROSS PIN FRAME; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PERCUTANEOUS REFERENCE CROSS PIN FRAME; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9732353
Medical Device Problem Codes Device Operates Differently Than Expected (2913); Material Deformation (2976)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 10/06/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.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.Part not returned for analysis.
 
Event or Problem Description
A site representative reported that, while outside of a procedure, the perc-pin locking mechanism was not functioning.There was no patient present when this issue was identified.No additional information was provided.
 
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Brand Name
PERCUTANEOUS REFERENCE CROSS PIN FRAME
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key7000226
Report Number1723170-2017-04460
Device Sequence Number1353932
Product Code OLO
UDI-Device Identifier00613994151179
UDI-Public00613994151179
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K131425
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 11/03/2017
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 Number9732353
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/06/2017
Initial Report FDA Received Date11/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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