MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVÓ DUAL MOTION BASE; SURGICAL PATIENT POSITIONER

Model Number	7887-010
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the levo base was slipping laterally during 180 degree rotations.At first it was perceived that the lateral lock was unlocked by an anesthesia line but later the slip was noticed due to the momentum of the 180 degree rotation.
Event or Problem Description
It was reported that the levo base was slipping laterally during 180 degree rotations.At first it was perceived that the lateral lock was unlocked by an anesthesia line but later the slip was noticed due to the momentum of the 180 degree rotation.
Additional Manufacturer Narrative
Based on findings from the device evaluation, the device failed the lateral load test.Examination of the brake arm assembly and carriage slide revealed the presence of brake debris combined with grease accumulation.These findings are identified as the primary contributing factors to brake assembly slippage and the resultant reduction in braking efficiency.Additionally, the device was received in an unclean condition, with post-surgical residue observed on the device, suggesting it may not have been cleaned in accordance with the manufacturer's recommended cleaning practices.It should be noted that conclusive evidence substantiating this as a direct contributing factor was not established during the investigation.The root cause of this incident is determined to be an isolated occurrence of brake slippage attributed to the accumulation of debris, residue, and grease within the carriage rail and brake arm assembly.It was also noted that "brake" was not the available option in the coding manual for the purposes of inserting in field component code(g) in section h6 adverse event problem.

• Brand Name: LEVÓ DUAL MOTION BASE
• Common Device Name: SURGICAL PATIENT POSITIONER
• 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: 24565097
• Report Number: 2921578-2026-00006
• Device Sequence Number: 13144618
• Product Code: JEA
• UDI-Device Identifier: 00842430104657
• UDI-Public: (01)00842430104657(10)MIZ240417(11)240417
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7887-010
• Device Catalogue Number: 7887-010
• Device Lot Number: MIZ240417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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
• Patient Sex: Unknown