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

Model Number	5943
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Paralysis (1997); Numbness (2415); Ambulation or Postural Difficulties (2544)
Date of Event	01/05/2015
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.".
Additional 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
• Common Device Name: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 10686104
• Report Number: 2921578-2020-00027
• Device Sequence Number: 10905389
• Product Code: JEA
• UDI-Device Identifier: 00842430105982
• UDI-Public: 00842430105982
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: No Information
• Device Model Number: 5943
• Device Catalogue Number: 5943
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2020
• Supplement Date Received by Manufacturer: 10/10/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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: Disability