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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FHC, INC. MICROTARGETING¿ WAYPOINT ANCHORS NEUROLOGICAL STEREOTAXIC INSTRUMENT

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FHC, INC. MICROTARGETING¿ WAYPOINT ANCHORS NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 66-WP-AN5
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/13/2017
Event Type  malfunction  
Event Description
Patient was undergoing a deep brain stimulator lead placement. Reportedly, tip of one of the fiducial screws broke off and was left in the patient's skull due to its small size. No patient harm was reported.
 
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Brand NameMICROTARGETING¿ WAYPOINT ANCHORS
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
FHC, INC.
1201 main st.
bowdoin ME 04287
MDR Report Key7167180
MDR Text Key96460609
Report Number7167180
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 12/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66-WP-AN5
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/21/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer12/21/2017
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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