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

Model Number	5943
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	06/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
From jardaly, a.Et al.Leg compartment syndrome complicating posterior spinal fusion for adolescent idiopathic scoliosis: a case report.American journal of case reports, 2021, 22: e927082.Https://www.Amjcaserep.Com/abstract/index/idart/927082.Patient with 59-degree left thoracic adolescent idiopathic scoliosis underwent posterior spinal instrumentation and fusion.The patient was placed prone on a jackson table frame.All pressure points were padded and pillows were placed under both of his legs.The surgery lasted 6 hours.On postoperative day 1, the patient complained of mild non-traumatic left leg pain, which became severe by day 2.A 4-compartment fasciotomy of the leg was immediately performed.Intraoperatively, the compartments were found to be bulging and a hematoma was noted.A wound vac was placed for drainage.The patient underwent irrigation and debridement of nonviable tissue (portions of the anterior tibialis, extensor hallucis longus, and extensor digitorum longus) with delayed primary wound closure.On follow-up, the patient has regained full ankle range of motion and has 5/5 dorsiflexion and plantar flexion.He has a weak ehl (1/5) but has been able to fully participate in sports.The causes of non-traumatic compartment syndrome are unclear, and assumed to be multifactorial.Excessive blood loss (5000 ml) likely contributed in this case.Other possible contributions include obesity, positioning on the operating table, selection of resuscitation fluids and associated agents to reduce coagulopathy, and intraoperative motor evoked potentials.

• 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 OSI; 30031 ahern av; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 12784025
• Report Number: 2921578-2021-00022
• Device Sequence Number: 20043682
• Product Code: JEA
• UDI-Device Identifier: 00842430105982
• UDI-Public: 00842430105982
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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: 5943
• Device Catalogue Number: 5943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 94 KG