MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. TRIOS CERVICAL MANAGEMENT BASE UNIT; SURGICAL PATIENT POSITIONER

Model Number	5979-1
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Trios spinal table with cmbu (cervical management base unit) was utilized for an anterior-posterior flip procedure on an 80-year-old patient weighing approximately 75-85 lbs.The hospital personnel had not performed this technique in approximately 10 years.Prior to the procedure, the initial reporter recommended rescheduling to allow for in-service training; this recommendation was declined by the assistant surgeon.During setup, the cmbu was attached with direction from the initial reporter.The surgeon tightened the connection of mayfield skull clamp with cmbu despite not being recommended by the initial reporter.The initial reporter intervened a second time to correct improper positioning of the chest plate and hip/thigh combination components before compression was attempted.Due to the patient's small frame, adequate compression could not be achieved.When the flat top was raised in an attempt to compensate, the mayfield skull clamp and cmbu were in a locked state, resulting in displacement of the skull pins posteriorly and causing lacerations to the patient.The procedure was halted.The spinal table was removed, and the patient was safely transferred to a bed.The table top was changed to a spinal top, and the patient remaining skull-clamped was repositioned onto the spinal top.Lacerations were stitched and the surgical case was subsequently continued.Both surgeons were spoken to following the event and reported they were doing well.
Additional Manufacturer Narrative
The lacerations were caused by skull pins that are not manufactured by mizuho orthopedic systems, inc.(dba- mizuho osi).Mayfield skull pins and skull clamp (non-mizuho osi products) were attached to mizuho osi trios cervical management base unit (cmbu) for the intended surgical procedure which is suspected to have contributed to the reported patient injury.
Additional Manufacturer Narrative
The lacerations were caused by skull pins that are not manufactured by mizuho orthopedic systems, inc.(dba- mizuho osi).Mayfield skull pins and skull clamp (non-mizuho osi products) were attached to mizuho osi trios cervical management base unit (cmbu) for the intended surgical procedure which is suspected to have contributed to the reported patient injury.Further investigation of this incident confirmed the part number and serial number of the mizuho osi product that was suspected to have contributed to the patient injury.The root cause of this incident is primarily attributed to use error.Specifically, no documented evidence was found to substantiate that hospital personnel were trained on either the theoretical components (as outlined in the owner's manual) or the practical operational aspects of the mizuho osi and mayfield devices in scope.Additionally, a failure to adhere to established best practices set forth by the device manufacturer was identified as the main causal factor.While patient stature may be considered a contributing factor, causative precedence is assigned to the use of the device beyond its intended design life and the failure to comply with manufacturer-defined best practices for patient safety.
Event or Problem Description
Trios spinal table with cmbu (cervical management base unit) was utilized for an anterior-posterior flip procedure on an 80-year-old patient weighing approximately 75-85 lbs.The hospital personnel had not performed this technique in approximately 10 years.Prior to the procedure, the initial reporter recommended rescheduling to allow for in-service training; this recommendation was declined by the assistant surgeon.During setup, the cmbu was attached with direction from the initial reporter.The surgeon tightened the connection of mayfield skull clamp with cmbu despite not being recommended by the initial reporter.The initial reporter intervened a second time to correct improper positioning of the chest plate and hip/thigh combination components before compression was attempted.Due to the patient's small frame, adequate compression could not be achieved.When the flat top was raised in an attempt to compensate, the mayfield skull clamp and cmbu were in a locked state, resulting in displacement of the skull pins posteriorly and causing lacerations to the patient.The procedure was halted.The spinal table was removed, and the patient was safely transferred to a bed.The table top was changed to a spinal top, and the patient remaining skull-clamped was repositioned onto the spinal top.Lacerations were stitched and the surgical case was subsequently continued.Both surgeons were spoken to following the event and reported they were doing well.

• Brand Name: TRIOS CERVICAL MANAGEMENT BASE UNIT
• Common Device Name: SURGICAL PATIENT POSITIONER
• 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: 24745395
• Report Number: 2921578-2026-00007
• Device Sequence Number: 18337910
• Product Code: JEA
• UDI-Device Identifier: 00842430106101
• UDI-Public: (01)00842430106101(10)MIZ090224(11)090224
• Combination Product (Y/N): N
• 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): 04/29/2026

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: 5979-1
• Device Catalogue Number: 5979-1
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2009
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Unknown
• Patient Weight: 39 KG