MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVO STANDARD PACKAGE; HEAD/NECK POSITIONER

Model Number	7887-300
Medical Device Problem Codes	Use of Device Problem (1670); Unintended Movement (3026)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the information obtained from the investigation, it was confirmed that the reported laceration injury was caused by non-mizuho orthopedic systems (dba-mizuho osi) devices (skull clamp and skull pins) mounted on mizuho osi device.Mizuho osi device performed as intended without any issues.While there were no functional issues reported with the skull clamp and skull pins (non-mizuho osi devices), these devices are planned to be returned to the legal manufacturer (pro med instruments gmbh/black forest medical group) for further analysis and evaluation.The reported patient injury is suspected to have been caused by a non-mizuho osi device due to its usage not according to the established specifications.Skull clamp was suspected to be not seated properly thus causing the skull pins to move and lacerate the patient's skull.The root cause of this incident is thus deemed as use error.
Event or Problem Description
During the surgical procedure, the device was applied to the patient and the operator confirmed a pinning pressure of 80 lbs.When repositioning of the patient's head was attempted, the patient was observed to have slid into a different position relative to the device.The procedure was completed; however, upon conclusion a 2-3 inch laceration was noted on the posterior aspect of the patient's head.

• Brand Name: LEVO STANDARD PACKAGE
• Common Device Name: HEAD/NECK 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: 25565746
• Report Number: 2921578-2026-00016
• Device Sequence Number: 15955602
• Product Code: JEA
• UDI-Device Identifier: 00842430114021
• UDI-Public: (01)00842430114021(11)251230
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 06/19/2026

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
• Operator of Device: Health Professional
• Device Model Number: 7887-300
• Device Catalogue Number: 7887-300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/19/2026
• Date Device Manufactured: 12/30/2025
• 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
• Patient Sex: Female