MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. ALUMINUM SWIVEL ADAPTER; HEAD POSITIONING

Model Number	5979-323
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	06/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the aluminum swivel adaptor ball joint of the cervical management base unit failed during surgery, allowing the patient's head to move, possibly causing injury.The patient complained of pain and numbness after surgery and was re-hospitalized.
Event or Problem Description
It was reported the aluminum swivel adaptor ball joint of the cervical management base unit failed during surgery, allowing the patient's head to move, possibly causing injury.The patient complained of pain and numbness after surgery and was re-hospitalized.
Additional Manufacturer Narrative
Verify little information was provided and the device was not made available for inspection.Unable to identify the cause of the problem.Device is over 10 years old.

• Brand Name: ALUMINUM SWIVEL ADAPTER
• Common Device Name: HEAD POSITIONING
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 10159320
• Report Number: 2921578-2020-00019
• Device Sequence Number: 3852214
• Product Code: JEA
• UDI-Device Identifier: 00842430113888
• UDI-Public: 00842430113888
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5979-323
• Device Catalogue Number: 5979-323
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2020
• Supplement Date Received by Manufacturer: 06/07/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization