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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC DILATOR 100MM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC DILATOR 100MM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9732565
Device Problem Device Handling Problem (3265)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 08/31/2020
Event Type  Injury  
Manufacturer Narrative
Device manufacturing date is unavailable at the time of filing. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar procedure. It was reported that the site had completed the clinical case and it was noted that the 100 millimeter perc pin dilator was left in the patient. There was no delay to the procedure as a result of this issue. The dilator was removed from the patient at a later date. There was no reported effect to the patient as a result of the dilator being left in and later being removed.
 
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Brand NameDILATOR 100MM
Type of DeviceINSTRUMENT, STEREOTAXIC
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10501851
MDR Text Key205909165
Report Number1723170-2020-02380
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9732565
Device Catalogue Number9732565
Device Lot Number190125
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 Received12/16/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/26/2019
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: 09/08/2020 Patient Sequence Number: 1
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