MAUDE Adverse Event Report: Mizuho Orthopedic Systems, Inc. Levo Arm; Head/neck procedure positioner

Model Number	7887-050
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury

• Brand Name: Levo Arm
• Common Device Name: Head/neck procedure positioner
• Manufacturer (Section D): Mizuho Orthopedic Systems, Inc.; 30031 ahern ave; union city CA 94587 -123
• Manufacturer (Section G): Mizuho Orthopedic Systems, Inc.; 30031 ahern ave; union city CA 94587 -123
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587--123 ; +1(510)429-1500
• MDR Report Key: 50569935
• Report Number: 2921578-2026-00025
• Device Sequence Number: 15966866
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: (01)00842430104992(11)20200111
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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?: No
• Operator of Device: Other
• Device Model Number: 7887-050
• Device Catalogue Number: 7887-050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown