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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FHC WAYPOINT STEREOTACTIC PLATFORM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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FHC WAYPOINT STEREOTACTIC PLATFORM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number MP-KIT-P-BI
Device Problems Malposition of Device (2616); Positioning Problem (3009); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2021
Event Type  Injury  
Event Description
After dbs bilateral lead placement surgery using starfix bilateral platform, it was noted that the post op ct revealed that on the left side the lead was placed appropriately, however the right side revealed in post op scans that the lead was 2. 8 cm deeper than expected. This did not cause a delay in dbs surgery, when the lead was placed. No harm to the patient was caused during the surgery. A revision surgery was completed the following day and released.
 
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Brand NameWAYPOINT STEREOTACTIC PLATFORM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
FHC
1201 main street
bowdoin ME 04287
Manufacturer (Section G)
FHC, INC.
1201 main street
bowdoin ME 04287
Manufacturer Contact
kelly moeykens
1201 main street
bowdoin, ME 04287
2076665651
MDR Report Key12821534
MDR Text Key280950644
Report Number3002250546-2021-00004
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092192
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMP-KIT-P-BI
Device Catalogue NumberMP-KIT-P-BI
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/16/2021 Patient Sequence Number: 1
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