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

Model Number	5979-1
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Device Slipped (1584)
Health Effect - Clinical Codes	Paralysis (1997); Insufficient Information (4580)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a starburst slip on a cervical management base unit during surgery.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2921578-2022-00022
• Device Sequence Number: 2810132
• Product Code: JEA
• UDI-Device Identifier: 00842430106101
• UDI-Public: 00842430106101
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

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