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

Model Number 5943

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Paralysis (1997); Numbness (2415); Ambulation Difficulties (2544)

Event Date 01/05/2015

Event Type  Injury  

Event Description

Per voluntary medwatch # mw5090314: "i had a spinal fusion at l4-l5.The restraint straps on the jackson table have left both my legs on the front only completely numb from 5 inches above my knees to 5 inches below my knees.The straps permanently cut off the circulation, nearly 5 years ago and no improvement.Also during same surgery the neuro-monitoring failed to show any signs of nerve damage, however i woke up paralyzed.It took 4 months to learn to walk again.Still very weak legs.This test confirmed nerve damage where i have numbness and weakness.".

Event Description

Per voluntary medwatch # mw5090314: "i had a spinal fusion at l4-l5.The restraint straps on the jackson table have left both my legs on the front only completely numb from 5 inches above my knees to 5 inches below my knees.The straps permanently cut off the circulation, nearly 5 years ago and no improvement.Also during same surgery the neuro-monitoring failed to show any signs of nerve damage, however i woke up paralyzed.It took 4 months to learn to walk again.Still very weak legs.This test confirmed nerve damage where i have numbness and weakness.".

Manufacturer Narrative

Cause could not be determined without additional information about the table and/or patient.Owner's manual nm0678 page 41 note: the placement and location of the straps are at the discretion of the surgeon and vary by procedure.

• Brand Name: MTS SPINAL SURGERY TOP
• Type of Device: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 10686104
• MDR Text Key: 213488808
• Report Number: 2921578-2020-00027
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430105982
• UDI-Public: 00842430105982
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5943
• Device Catalogue Number: 5943
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability