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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION BIOPSY EXTERNAL TRAJECTORY GUIDE KIT NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NEUROMODULATION BIOPSY EXTERNAL TRAJECTORY GUIDE KIT NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Lot Number 066231119A
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/17/2020
Event Type  malfunction  
Event Description
A screw used to secure holder onto skull broke off into pts skull. It did not affect anything other than slight increase in operating time. Fda safety report id# (b)(4).
 
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Brand NameBIOPSY EXTERNAL TRAJECTORY GUIDE KIT
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
MDR Report Key9805268
MDR Text Key182894516
Report NumberMW5093614
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number066231119A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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