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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 Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/23/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No findings possible, as the damaged part has not been received by the manufacturer for evaluation.
 
Event or Problem Description
A medtronic representative reported that prior to a procedure, the surgeon noticed a loose spring in the patient reference frame.There was no patient present when this issue was identified.No additional details were 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 Key6189775
Report Number1723170-2016-05857
Device Sequence Number914506
Product Code OLO
UDI-Device Identifier00613994151179
UDI-Public00613994151179
Combination Product (Y/N)N
Initial Reporter StateTN
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) 12/20/2016
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
Device Lot Number120217
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/23/2016
Initial Report FDA Received Date12/20/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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