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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC UNIVERSAL DRILL GUIDE NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC UNIVERSAL DRILL GUIDE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735196
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2022
Event Type  malfunction  
Manufacturer Narrative
No parts have been sent back for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that the universal drill guide was not locking and needed to be replaced. The bit stop was damaged, would not lock in place on the drill guide.
 
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Brand NameUNIVERSAL DRILL GUIDE
Type of DeviceNEUROLOGICAL 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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13527835
MDR Text Key289213035
Report Number1723170-2022-00198
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
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
Report Date 02/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735196
Device Catalogue Number9735196
Was Device Available for Evaluation? No
Date Manufacturer Received01/24/2022
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

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