MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HALF TRACK; ROLLER BOARD, PRODUCT CODE

Model Number	901
Medical Device Problem Codes	Connection Problem (2900); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer purchased a half track and they were using it to transfer a patient and during this transfer the part disassembled.No patient injury occured.
Additional Manufacturer Narrative
Based on the information obtained from the investigation of the returned device showed brace tubes had seperated from the end plate.The specified dimension from the end plate edge to the center of the hole is 4 × 0.18".The measurements from the returned part were found to be out of specification.
Event or Problem Description
Customer purchased a half track and they were using it to transfer a patient and during this transfer the part disassembled.No patient injury occured.

• Brand Name: HALF TRACK
• Common Device Name: ROLLER BOARD, PRODUCT CODE
• 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: 24445065
• Report Number: 2921578-2026-00002
• Device Sequence Number: 13325578
• Product Code: FMR
• UDI-Device Identifier: 00842430107429
• UDI-Public: (01)00842430107429(10)MIZ250813(11)220813
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 901
• Device Catalogue Number: 901
• Device Lot Number: MIZ250813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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