MAUDE Adverse Event Report: AMENDIA IO-FLEX; MANUAL RONGEUR

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.

• Brand Name: IO-FLEX
• Type of Device: MANUAL 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 Key: 6455462
• MDR Text Key: 71579961
• Report Number: 1067095-2017-00004
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• 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 Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: IO-NCW
• Device Lot Number: 15816
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention