MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. ADVANCED CONTROL I-BASE, DC; OPERATING TABLE

Model Number	5803
Medical Device Problem Codes	Use of Device Problem (1670); Device Fell (4014)
Health Effect - Clinical Codes	Fall (1848); Insufficient Information (4580)
Date of Event	03/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgery wrong h frame pin was pulled by staff causing the patient to fall.
Additional Manufacturer Narrative
Per the information obtained from investigation, no problems with the device were reported.User failed to secure the tabletop with a t-pin through the mounting tube thus causing a patient fall during the transfer from the floor bed.Patient was subjected to a ct scan following the fall but it came out to be normal.No injury was reported.The ifu was reviewed and found to be sufficient with warnings regarding the usage of t-pins.The incident has thus been deemed as a use error as there was a failure to follow instructions and recommended practices for patient safety and device usage.Educational in-service was conducted by the manufacturer following this incident.
Event or Problem Description
It was reported that during a surgery wrong h frame pin was pulled by staff causing the patient to fall.

• Brand Name: ADVANCED CONTROL I-BASE, DC
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 21688158
• Report Number: 2921578-2025-00007
• Device Sequence Number: 15773546
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: (01)00842430106026(11)130402
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2013
• 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: Male