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

Model Number	5943
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the spine tabletop attached to the table base came loose and appeared to be separated from the mount at two different points resulting in a structural failure.The tabletop also showed significant signs of wear, including rust and a buildup of residue.There wasn't any visual damage to the carbon fiber.The patient is okay at this time.
Event or Problem Description
It was reported that during surgery the spine tabletop attached to the table base came loose and appeared to be separated from the mount at two different points resulting in a structural failure.The tabletop also showed significant signs of wear, including rust and a buildup of residue.There wasn't any visual damage to the carbon fiber.The patient is okay at this time.
Additional Manufacturer Narrative
Per the information obtained from investigation and device evaluation, the device (mts spine tabletop) showed significant signs of wear and residue that resulted in the structural failure during surgery thus causing the patient to fall and sustain a broken nose.The injury was mitigated by the hospital by maintaining the sterile field and treating the patient for any infections.The age of the tabletop is suspected to be 20+ years (mfg date- 11/29/2005).The table base also showed the signs built-up residue and rust on the head end.The hospital was notified by the distributor regarding the age of the spine top and a recommendation to replace it with a newer tabletop.This incident is thus deemed as a use error due to the below listed reasons that point towards user not following the recommended practices of patient safety and device usage per the manufacturer's instructions.1.Evidence of using a tabletop that was well beyond its design life (10 years) as specified in the owner's manual.2.Using an uncleaned table base and tabletop for the surgical procedure 3.Improper maintenance and check of the table base and tabletop prior and following its usage as recommended in the owner's manual.

• 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: 21532247
• Report Number: 2921578-2025-00006
• Device Sequence Number: 7857456
• Product Code: JEA
• UDI-Device Identifier: 00842430105982
• UDI-Public: (01)00842430105982(11)051129
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5943
• Device Catalogue Number: 5943
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 05/03/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2005
• 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