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

Model Number	6875
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Pressure Sore/Ulcer (2326)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During a daa tha with femoral head autograft acetabular reconstruction for hip dysplasia on a hana table, the patient experienced partial vulvar pressure necrosis from the perineal post.Mentioned in retrospective review of case series "femoral head autograft can reliably reconstruct dysplastic acetabula through the direct anterior approach for total hip arthroplasty" by taylor et al in arthroplasty today, https://doi.Org/10.1016/j.Artd.2022.02.005.
Additional Manufacturer Narrative
This event was identified in a literature report found online as part of post-market surveillance activities.Attempts were made to reach the author to perform investigation pertaning to the observed adverse event but a response was not obtained.
Event or Problem Description
During a daa tha with femoral head autograft acetabular reconstruction for hip dysplasia on a hana table, the patient experienced partial vulvar pressure necrosis from the perineal post.Mentioned in retrospective review of case series "femoral head autograft can reliably reconstruct dysplastic acetabula through the direct anterior approach for total hip arthroplasty" by taylor et al in arthroplasty today, https://doi.Org/10.1016/j.Artd.2022.02.005.

• Brand Name: HANA ORTHOPEDIC SURGERY TABLE
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 19705742
• Report Number: 2921578-2024-00008
• Device Sequence Number: 3690153
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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: 6875
• Device Catalogue Number: 6875
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2024
• Supplement Date Received by Manufacturer: 06/22/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown