MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVÓ; HEAD POSITIONING UNIT

Model Number	7887-050
Medical Device Problem Codes	Electrical Shorting (2926); Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 30 to 45 minutes into this case the surgeons noticed that the head of the patient was slowly moving downward.One surgeon had to break scrub to stop it from moving down any further while the other surgeon held the patient's head at the skull clamp.
Additional Manufacturer Narrative
It is evidence through the investigation of the returned unit, that some fluid ingress caused short circuit between the connector and the wires.This resulted in the joints to remain open and not hold in lock position.The ball joint appears to have over heated and damage the ball joint motor.It is unknown if proper cleaning method as instructed in the owner's manual was applied.
Event or Problem Description
It was reported that 30 to 45 minutes into this case the surgeons noticed that the head of the patient was slowly moving downward.One surgeon had to break scrub to stop it from moving down any further while the other surgeon held the patient's head at the skull clamp.
Additional Manufacturer Narrative
It is evidence through the investigation of the returned unit, that some fluid ingress caused short circuit between the connector and the wires.This resulted in the joints to remain open and not hold in lock position.The ball joint appears to have over heated and damage the ball joint motor.It is unknown if proper cleaning method as instructed in the owner's manual was applied.
Event or Problem Description
It was reported that 30 to 45 minutes into this case the surgeons noticed that the head of the patient was slowly moving downward.One surgeon had to break scrub to stop it from moving down any further while the other surgeon held the patient's head at the skull clamp.

• Brand Name: LEVÓ
• Common Device Name: HEAD POSITIONING UNIT
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8903051
• Report Number: 2921578-2019-00031
• Device Sequence Number: 10823763
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: 00842430104992
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2019

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: 7887-050
• Device Catalogue Number: 7887-050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 08/21/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 10/03/2019; 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2921578-10/16/2019-001-R
• Patient Sequence Number: 1