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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONTERIS MEDICAL INC. AXIIIS STEREOTACTIC MINIFRAME NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MONTERIS MEDICAL INC. AXIIIS STEREOTACTIC MINIFRAME NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number AX300-01
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 01/27/2016
Event Type  malfunction  
Event Description
According to the surgeon, a screw was placed and tighten down in the axis frame and broke off.
 
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Brand NameAXIIIS STEREOTACTIC MINIFRAME
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MONTERIS MEDICAL INC.
14755 27th ave n ste. c
plymouth MN 55446
MDR Report Key5623613
MDR Text Key44139309
Report Number5623613
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/28/2016,04/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAX300-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/28/2016
Event Location Hospital
Date Report to Manufacturer01/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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