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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CRANIAL REFERENCE FRAME, SMALL PASSIVE NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC CRANIAL REFERENCE FRAME, SMALL PASSIVE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 961-337
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2021
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. No parts have been received by the manufacturer for evaluation. 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. The site reported the small cranial reference frame pin was bent. The frame would be replaced. There was no patient involvement. Additional information was received stating that the reported cause of the event was that the small frame shut down on the floor, or that the pin was stuck in the sterilization grid.
 
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Brand NameCRANIAL REFERENCE FRAME, SMALL PASSIVE
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 Key13112739
MDR Text Key290281571
Report Number1723170-2021-02983
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number961-337
Device Catalogue Number961-337
Device Lot Number181010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/10/2018
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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