MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. CHEST SUPPORT SECTION ASSY.; OPERATING TABLE TORSO POSITIONER

Model Number	5840-580
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Adult female to operating room for treatment of t12 burst fracture sustained status post a fall out of bed a week earlier.Planned procedure was open treatment, reduction, and kyphoplasty t12 with tll-ll posterolateral bone fusion and pedicle screw instrumentation.Patient is morbidly obese, wt: (b)(6) lb, bmi: 50.Patient was positioned prone for surgery on trios table at 1351.At 1358 a loud crack was heard and the patient was noted to have settled into the table frame.The chest support on the table had cracked and completely fallen off.The patient was resting on the two rails of the table, supported by her body and shoulders.There was no obvious hyperextension, malalignment, or injury noted.The incision was quickly closed and the patient was turned supine onto a stretcher at 1400.A replacement chest support was obtained and the patient was repositioned prone at 1404.The patient was then re-prepped and re-draped and surgery proceeded as planned.No obvious injuries were noted upon returning the patient to the supine position post-op.No additional diagnostic imaging was obtained related to this incident.The weight limit of the trios table is 600lbs.
Additional Manufacturer Narrative
Based on interview with customer (and without having device) it was determined the crack occurred from improper removal of chest plate.Training has taken place for the staff on proper setup.In addition mizuho osi has the steps located in the user manual which was also pointed out when there is help / questions.
Event or Problem Description
Adult female to operating room for treatment of t12 burst fracture sustained status post a fall out of bed a week earlier.Planned procedure was open treatment, reduction, and kyphoplasty t12 with tll-ll posterolateral bone fusion and pedicle screw instrumentation.Patient is morbidly obese, wt: 290 lb, bmi: 50.Patient was positioned prone for surgery on trios table at 1351.At 1358 a loud crack was heard and the patient was noted to have settled into the table frame.The chest support on the table had cracked and completely fallen off.The patient was resting on the two rails of the table, supported by her body and shoulders.There was no obvious hyperextension, malalignment, or injury noted.The incision was quickly closed and the patient was turned supine onto a stretcher at 1400.A replacement chest support was obtained and the patient was repositioned prone at 1404.The patient was then re-prepped and re-draped and surgery proceeded as planned.No obvious injuries were noted upon returning the patient to the supine position post-op.No additional diagnostic imaging was obtained related to this incident.The weight limit of the trios table is 600lbs.

• Brand Name: CHEST SUPPORT SECTION ASSY.
• Common Device Name: OPERATING TABLE TORSO POSITIONER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 12159320
• Report Number: 2921578-2021-00018
• Device Sequence Number: 3857053
• Product Code: JEA
• UDI-Device Identifier: 00842430104343
• UDI-Public: 00842430104343
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: 5840-580
• Device Catalogue Number: 5840-580
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 132