MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVÓ; HEAD POSITIONING UNIT

Model Number	7887-050
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During cervical spine case the arm was moving from the ball joint area of the device without engaging control handles.Patient's head was connected to skull clamp and attached via quick connect.Surgeon could manually move the head by pushing on control handles to create full range of motion without press light blue or dark blue buttons.
Event or Problem Description
During cervical spine case the arm was moving from the ball joint area of the device without engaging control handles.Patient's head was connected to skull clamp and attached via quick connect.Surgeon could manually move the head by pushing on control handles to create full range of motion without press light blue or dark blue buttons.
Additional Manufacturer Narrative
Root cause of the ball joint lock failure was improper installation of an internal retaining ring resulting in a failed bearing that caused the ball joint locking mechanism to fall in an unlocked state.

• Brand Name: LEVÓ
• Common Device Name: HEAD POSITIONING UNIT
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 7728259
• Report Number: 2921578-2018-00029
• Device Sequence Number: 11012018
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: 00842430104992
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2019

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: 7887-050
• Device Catalogue Number: 7887-050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1