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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAV 4.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAV 4.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9734238
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2017
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative inspected the navigation system onsite and replaced the taps.The system was returned to service.Device manufacturing date is dependent on lot number, therefore, unavailable at this time.The suspect part has not been returned to the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that while in a sacroiliac and thoracolumbar procedure the k wire was getting "stuck" in the taps.One surgeon was holding the k wire while another was manipulating the tap to get it off around the k wire and was successful.The site is proceeding with universal drill guide (udg) to create a hole and a non-medtronic tap to continue without issue.There was a reported delay to the procedure of less than 10 minutes due to this issue and no impact on the patient outcome.
 
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Brand Name
NAV 4.5MM TAP (CANNULATED)
Type of Device
ORTHOPEDIC 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
stephanie riley
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7182467
MDR Text Key97104674
Report Number1723170-2018-00181
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K124004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 01/11/2018
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
Device Operator Physician
Device Catalogue Number9734238
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2017
Initial Date FDA Received01/11/2018
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
Patient Sequence Number1
Patient Age68 YR
Patient Weight82
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