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

Model Number	7887-050
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during his case he thought the patient's head "moved'.The surgeon and his tech said it might have moved but they were not sure it was the positioner or something else.The case went on without any issue.
Event or Problem Description
It was reported that during his case he thought the patients head "moved'.The surgeon and his tech said it might have moved but they were not sure it was the positioner or something else.The case went on without any issue.
Additional Manufacturer Narrative
A broken ground wire may have contributed to the claim of unintended motion; however the failure was not reproducible during al testing scenarios performed.

• Brand Name: LEVO ARM
• Common Device Name: HEAD/NECK PROCEDURE POSITIONER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca CA 94587 1234
• MDR Report Key: 9497523
• Report Number: 2921578-2019-00049
• Device Sequence Number: 2080194
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: 00842430104992
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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: 01/16/2020
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1