MAUDE Adverse Event Report: Mizuho Orthopedic Systems, Inc. ADVANCED CONTROL I-BASE, DC; Operating Tables

Model Number	5803
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/11/2026
Type of Reportable Event	Serious Injury

• Brand Name: ADVANCED CONTROL I-BASE, DC
• Common Device Name: Operating Tables
• 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: 50941505
• Report Number: 2921578-2026-00028
• Device Sequence Number: 16139642
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: (01)00842430106026(11)2011
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 5803
• Device Catalogue Number: 5803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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