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

Model Number	5943
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Stenosis (2263)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two positioning-related problems reported in an obese patient undergoing surgery for spinal fracture on an open frame tabletop.Significant bruising across iliac crest and groin noted postoperatively, attributed to pressure from the hip/thigh pads.That pressure is also suspected as the cause of a significant loss of lower extremity nerve conduction signals during the procedure.The weight of the sagging pannus destabilized the fracture.The surgical team was alerted to the problem via neuromonitoring and was able to repair the injury.The surgeons suggest that bariatric security straps might have relieved some of the excess gravitational force extending the spine.From nicholas a.Streltzov, linton t.Evans, m.Dustin boone, brandon k.Root, daniel r.Calnan, erik j.Kobylarz, yinchen song, intraoperative neurophysiological monitoring of t9-t10 fracture in a patient with morbid obesity and ankylosing spondylitis: a case report with literature review, clinical neurophysiology practice, 2021, issn 2467-981x, https://doi.Org/10.1016/j.Cnp.2021.02.004 (https://www.Sciencedirect.Com/science/article/pii/s2467981x2100010x).
Event or Problem Description
It was reported that two positioning-related problems reported in an obese patient undergoing surgery for spinal fracture on an open frame tabletop.Significant bruising across iliac crest and groin noted postoperatively, attributed to pressure from the hip/thigh pads.That pressure is also suspected as the cause of a significant loss of lower extremity nerve conduction signals during the procedure.The weight of the sagging pannus destabilized the fracture.The surgical team was alerted to the problem via neuromonitoring and was able to repair the injury.The surgeons suggest that bariatric security straps might have relieved some of the excess gravitational force extending the spine.From nicholas a.Streltzov, linton t.Evans, m.Dustin boone, brandon k.Root, daniel r.Calnan, erik j.Kobylarz, yinchen song, intraoperative neurophysiological monitoring of t9-t10 fracture in a patient with morbid obesity and ankylosing spondylitis: a case report with literature review, clinical neurophysiology practice, 2021, issn 2467-981x, https://doi.Org/10.1016/j.Cnp.2021.02.004 (https://www.Sciencedirect.Com/science/article/pii/s2467981x2100010x).
Additional Manufacturer Narrative
As noted in the article, the patient was morbidly obese, which contributed to undesired extension of the spine during a minimally invasive procedure.There is no issue with the product itself in function or specifications.There are various factors to consider and manage with dealing with obese patients; however, there was no product failure based on the report.

• Brand Name: MTS SPINAL SURGERY TOP
• Common Device Name: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 11602465
• Report Number: 2921578-2021-00010
• Device Sequence Number: 19947190
• Product Code: JEA
• UDI-Device Identifier: 00842430105982
• UDI-Public: 00842430105982
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 07/13/2021
• 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 Age: 45 YR