MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. TRIOS/STS CHEST PAD SUPPORT PLATE; POSITIONER

Model Number	5840-580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was transferred off of the table and the staff noticed the broken pad base.It was found the mizuho osi chest pad and support plate were being used on an allen spine frame.
Additional Manufacturer Narrative
Hospital disposed of the chest support section assembly.Hospital used chest support section assembly on an allen spine frame, which has not been tested for proper performance when used and therefore are not endorsed for use by mizuho osi.Hospital disposed of the part.
Event or Problem Description
Patient was transferred off of the table and the staff noticed the broken pad base.It was found the mizuho osi chest pad and support plate were being used on an allen spine frame.

• Brand Name: TRIOS/STS CHEST PAD SUPPORT PLATE
• Common Device Name: POSITIONER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca
• MDR Report Key: 9728878
• Report Number: 2921578-2020-00008
• Device Sequence Number: 19453505
• Product Code: JEA
• UDI-Device Identifier: 00842430104343
• UDI-Public: 00842430104343
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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: 5840-580
• Device Catalogue Number: 5840-580
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1