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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIKON SURGICAL, LLC 3 MM KERRISON RONGEUR, MANUAL

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VIKON SURGICAL, LLC 3 MM KERRISON RONGEUR, MANUAL Back to Search Results
Catalog Number VKV803QR
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/07/2020
Event Type  malfunction  
Event Description
The base plate of the kerrison broke off during procedure, all pieces obtained. Fda safety report id #: (b)(4).
 
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Brand Name3 MM KERRISON
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
VIKON SURGICAL, LLC
2719 19th street south
homewood AL 35209
MDR Report Key9977246
MDR Text Key188689876
Report NumberMW5094196
Device Sequence Number1
Product Code HAE
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 04/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVKV803QR
Was Device Available for Evaluation? No
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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