MAUDE Adverse Event Report: MIZUHO OSI TRIOS CERVICAL MANAGEMENT BASE UNIT

Model Number 5979-1

Device Problems Use of Incorrect Control/Treatment Settings (1126); Device Slipped (1584)

Patient Problems Paralysis (1997); Insufficient Information (4580)

Event Date 09/09/2022

Event Type  malfunction  

Event Description

It was reported that there was a starburst slip on a cervical management base unit during surgery.

Manufacturer Narrative

After evaluating the unit, it was found that there were no issues with the unit, and it was functioning as per the specifications.Based on the information received from the investigation, it was concluded that the user failed to secure the teeth of the starburst connection of the device thus not following the instructions as per the owner's manual which mention "failure to ensure that all the teeth of the starbursts are aligned and the knobs are properly tightened may cause harm to the patient, healthcare professional or the device".Per the communication with the hospital personnel, the patient did temporarily lose some bodily function but was able to recover without any observable injury.

Event Description

It was reported that there was a starburst slip on a cervical management base unit during surgery.

• Brand Name: TRIOS CERVICAL MANAGEMENT BASE UNIT
• Type of Device: CERVICAL MANAGEMENT BASE UNIT
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 15584333
• MDR Text Key: 307029339
• Report Number: 2921578-2022-00022
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430106101
• UDI-Public: 00842430106101
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5979-1
• Device Catalogue Number: 5979-1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1