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	08/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the ball joint would not stay in locked position while the skull clamp was attached to patient.
Event or Problem Description
It was reported the ball joint would not stay in locked position while the skull clamp was attached to patient.
Additional Manufacturer Narrative
Received device and verified that the ball joint moves freely.Investigation is in progress.
Additional Manufacturer Narrative
Received device and verified that the ball joint moves freely.There is a bronze bushing that manufacturing failed to install.
Event or Problem Description
It was reported the ball joint would not stay in locked position while the skull clamp was attached to patient.

• 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: 8902857
• Report Number: 2921578-2019-00033
• Device Sequence Number: 18895631
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: 00842430104992
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2019

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: 08/20/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 08/21/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/17/2019; 10/15/2019
• Patient Sequence Number: 1