MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVÓ; HEAD/NECK PROCEDURE POSITIONER

Model Number	7887-010
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure when doctor was placing in screws into the patient surgical area; the levo locks became unlocked and the levo dual motion base tilted up.This resulted into the patient head tilting downward while the surgeon was placing in the screws.
Additional Manufacturer Narrative
Investigation is underway, will provide updates as they become available.
Event or Problem Description
During the procedure when doctor was placing in screws into the patient surgical area; the levo locks became unlocked and the levo dual motion base tilted up.This resulted into the patient head tilting downward while the surgeon was placing in the screws.
Event or Problem Description
During the procedure when doctor was placing in screws into the patient surgical area; the levo locks became unlocked and the levo dual motion base tilted up.This resulted into the patient head tilting downward while the surgeon was placing in the screws.
Additional Manufacturer Narrative
Variability in spar height was contributing to this failure mode.Due to a specification defect that did not specify the range of spar size limits, the spar clamp design had a potential for unlocking of the spar clamps.Assembly and test methods did not include spar clamp function verification over the range of spar sizes.The design has been updated with more compliant bumpers to address the range of sizes and a shimming process to tune each clamp for mechanical component tolerances, using updated production tooling.The devices in the field have been replaced with this release design.

• Brand Name: LEVÓ
• Common Device Name: HEAD/NECK PROCEDURE POSITIONER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 7711653
• Report Number: 2921578-2018-00028
• Device Sequence Number: 2644348
• Product Code: JEA
• UDI-Device Identifier: 00842430104657
• UDI-Public: 00842430104657
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Remedial Action: Replace,Repair,Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 07/17/2018; 07/17/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/24/2018; 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 105