MAUDE Adverse Event Report: Mizuho Orthopedic Systems, Inc. TABLE, HANA, 110 V; Operating Table

Model Number	6875
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A posting from the ahf podcast (on linkedin) highlighted a case where the foot slipped from the boot during a case resulting in a periprosthetic fracture.The patient was reported to be obese and had fit issues with the boot and the foot slipped from the boot under traction leading to a fracture during a revision case.The surgery was completed after resolving the issue.

• Brand Name: TABLE, HANA, 110 V
• Common Device Name: Operating Table
• 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: 50776603
• Report Number: 2921578-2026-00026
• Device Sequence Number: 16140901
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: (01)00842430108747
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: Health Professional
• Device Model Number: 6875
• Device Catalogue Number: 6875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female