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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) REFERENCE FRAME - SMALL PASSIVE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) REFERENCE FRAME - SMALL PASSIVE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9730605
Device Problem Calibration Problem (2890)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information not provided due to japanese patient privacy regulations. Missing lot number and udi. Missing device manufacture date. No parts have been returned to the manufacturer for analysis. Parts not returned.
 
Event Description
Medtronic received information regarding a navigation device. It was reported that the site received a small passive frame recognition failure. There was no impact to patient. There was no reported delay to the procedure due to this issue.
 
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Brand NameREFERENCE FRAME - SMALL PASSIVE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
maxwell roth
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7794914
MDR Text Key117573483
Report Number1723170-2018-04108
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9730605
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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