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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMENDIA IO-FLEX MANUAL RONGEUR

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AMENDIA IO-FLEX MANUAL RONGEUR Back to Search Results
Model Number IO-NCW
Device Problem Material Fragmentation (1261)
Patient Problem No Code Available (3191)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
A csf leak was reported, however the surgeon determined no further patient intervention or monitoring was required.
 
Event Description
Wire in device broke and a fragment had to be retrieved from the patient.
 
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Brand NameIO-FLEX
Type of DeviceMANUAL RONGEUR
Manufacturer (Section D)
AMENDIA
1755 west oak parkway
marietta GA 30062
Manufacturer (Section G)
AMENDIA
1755 west oak parkway
marietta GA 30062
Manufacturer Contact
bruce hooper
1755 west oak parkway
marietta, GA 30062
8777553329
MDR Report Key6455462
MDR Text Key71579961
Report Number1067095-2017-00004
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110696
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 04/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIO-NCW
Device Lot Number15816
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/03/2017 Patient Sequence Number: 1
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