MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. WILSON PLUS RADIOLUCENT FRAME UNIVERSAL; SURGICAL OPERATING TABLE

Model Number	5319G
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Skin Irritation (2076); Pressure Sore/Ulcer (2326)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was positioned on mizuho black wilson frame for spine procedure.Procedure lasted 3 hours 13 minutes.After procedure patient flipped back supine.Red, blistered areas noted down both sides of patient where the patient was resting on the foam pads.Pads had been replaced on the frame around six months ago.Frame has been used many times since then.Disposable sheet from our custom turnover kit was used to cover the frame.Silvadene cream used to treat patient wounds.Patient discharged and will receive treatment in outpatient wound center.
Additional Manufacturer Narrative
A disposable sheet from a turnover kit was placed on the frame between the patient and the pads.The pads did not show wear and have been in use for several months.The patient was not obese, nor was the case long.The use of extra material between the patient and the pads combined with the patient noted perspiration likely contributed to the pressure issues reported.The customer indicated that since reporting this issue, they have continued to use the frame with no further incidents.
Event or Problem Description
Patient was positioned on mizuho black wilson frame for spine procedure.Procedure lasted 3 hours 13 minutes.After procedure patient flipped back supine.Red, blistered areas noted down both sides of patient where the patient was resting on the foam pads.Pads had been replaced on the frame around six months ago.Frame has been used many times since then.Disposable sheet from our custom turnover kit was used to cover the frame.Sivadene cream used to treat patient wounds.Patient discharged and will receive treatment in outpatient wound center.

• Brand Name: WILSON PLUS RADIOLUCENT FRAME UNIVERSAL
• Common Device Name: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca
• MDR Report Key: 10135704
• Report Number: 2921578-2020-00018
• Device Sequence Number: 11668280
• Product Code: JEA
• UDI-Device Identifier: 00842430110238
• UDI-Public: 00842430110238
• 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,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5319G
• Device Catalogue Number: 5319G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 96