MAUDE Adverse Event Report: MIZUHO OSI WILSON PLUS UNIVERSAL W/TEMPUR PADS; PATIENT POSITIONER

Model Number	5319G
Medical Device Problem Codes	Collapse (1099); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lumbar disectomy, the right side rail of wilson frame came loose and collapsed.The patient was caught/secured so as to avoid the fall and was reported to be okay.
Additional Manufacturer Narrative
Inspection of the device found no defects apart from the detached fastener.The manual warns users to inspect the device before and after each use.
Event or Problem Description
It was reported that during a lumbar disectomy, the right side rail of wilson frame came loose and collapsed.The patient was caught/secured so as to avoid the fall and was reported to be okay.

• Brand Name: WILSON PLUS UNIVERSAL W/TEMPUR PADS
• Common Device Name: PATIENT POSITIONER
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 17044538
• Report Number: 2921578-2023-00008
• Device Sequence Number: 15638069
• Product Code: JEA
• UDI-Device Identifier: 00842430105104
• UDI-Public: 00842430105104
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 5319G
• Device Catalogue Number: 5319G
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• 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: 43 YR
• Patient Sex: Unknown
• Patient Weight: 116 KG