MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. SPINAL SURGERY TOP; OPERATING TABLE

Model Number	5840-831
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tabletop was beyond its 10-year lifetime.Inspection showed signed of corrosion and disbonding.Unclear if the user's annual inspections included checks for adhesive joint loosening.
Event or Problem Description
With patient prone on table and surgery in progress, the tabletop broke apart and fell onto the c-arm.No injuries.
Event or Problem Description
With patient prone on table and surgery in progress, the tabletop broke apart and fell onto the c-arm.No injuries.
Additional Manufacturer Narrative
Tabletop was beyond its 10-year lifetime.Inspection showed signs of corrosion and disbonding.Preventive maintenance inspections including checks for adhesive joint loosening are required at least annually during the device lifetime.

• Brand Name: SPINAL SURGERY TOP
• Common Device Name: OPERATING TABLE
• 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: 12666025
• Report Number: 2921578-2021-00020
• Device Sequence Number: 11064291
• Product Code: JEA
• UDI-Device Identifier: 00842430114427
• UDI-Public: 00842430114427
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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: 5840-831
• Device Catalogue Number: 5943AP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2007
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 109 KG