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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAV THORACIC PROBE TIP ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC NAV THORACIC PROBE TIP ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734680
Device Problem Material Integrity Problem (2978)
Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2019
Event Type  malfunction  
Manufacturer Narrative
Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding navigation instruments being used intra-operatively of a sacroiliac and thoracolumbar procedure. It was reported that the navlock thoracic probe broke off in the patient at the 20mm mark. They swapped to the lumbar probe and the lumbar probe tip twisted. These instruments are from the new tray. The issue extended the surgical time by less than 1 hour. There was no impact on the patient outcome.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information: the surgeon left a portion of the instrument inside the patient.
 
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Brand NameNAV THORACIC PROBE TIP
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9311513
MDR Text Key178334712
Report Number1723170-2019-05576
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734680
Device Catalogue Number9734680
Device Lot Number190417
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/12/2019 Patient Sequence Number: 1
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