MAUDE Adverse Event Report: JACKSON TABLE RESTRAINT STRAPS; TABLE AND ATTACHMENTS, OPERATING-ROOM

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

Patient Problems Paralysis (1997); Weakness (2145); Numbness (2415); Ambulation Difficulties (2544); Vascular System (Circulation), Impaired (2572)

Event Date 01/05/2015

Event Type  Injury  

Event Description

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.Fda safety report id # (b)(4).

• Brand Name: JACKSON TABLE RESTRAINT STRAPS
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• MDR Report Key: 9172893
• MDR Text Key: 161924459
• Report Number: MW5090314
• Device Sequence Number: 2
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/06/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 52 YR
• Patient Weight: 102