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 Codes	Bone Fracture(s) (1870); Vertebral Fracture (4520)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reporter was contacted to provide additional details regarding the event; however, he confirmed that he was not present at the time of the incident and that the case report was written at a later date.Reported in "l1 fracture subluxation in patient with diffuse idiopathic skeletal hyperostosis diagnosed after hip fracture nail: a case report" ( ng, kelvin md; wengle, lawrence md, frcsc; veillette, christian md, msc, frcsc; leroux, timothy md, med, frcsc).Jbjs case connector 15(4):e25.00344, october-december 2025.| doi: 10.2106/jbjs.Cc.25.00344.
Event or Problem Description
An elderly man with hip and rib fractures underwent hip nailing on a hana table under spinal anesthesia and later developed complete lower extremity paralysis.Imaging revealed an l1 fracture with subluxation and cord compression, requiring emergency decompression and fusion, without neurologic recovery.It remains unclear whether the spinal injury was pre existing or displaced during surgery, with hindsight suggesting underlying spinal ankylosis (dish) and that additional spinal imaging or alternative positioning may have reduced risk.
Additional Manufacturer Narrative
This event was identified during a literature review.The lot number of the devices was not obtained, and the author of the case report was contacted as part of the investigation; however, it was confirmed that the reporter was not present during the event.Due to insufficient information regarding the incident and the device, the investigation could not be fully completed, and the root cause of the event remains inconclusive.
Event or Problem Description
An elderly man with hip and rib fractures underwent hip nailing on a hana table under spinal anesthesia and later developed complete lower extremity paralysis.Imaging revealed an l1 fracture with subluxation and cord compression, requiring emergency decompression and fusion, without neurologic recovery.It remains unclear whether the spinal injury was pre existing or displaced during surgery, with hindsight suggesting underlying spinal ankylosis (dish) and that additional spinal imaging or alternative positioning may have reduced risk.

• Brand Name: TABLE, HANA, 110 V
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 24573106
• Report Number: 2921578-2026-00003
• Device Sequence Number: 20921570
• Product Code: JEA
• UDI-Device Identifier: 00842430101656
• UDI-Public: (01)00842430101656
• 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: Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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
• 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: 02/22/2026
• Supplement Date Received by Manufacturer: 02/22/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/16/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown