MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. CERVICAL TRACTION VECTOR ADJUSTER; TRACTION ADJUSTER

Model Number 7803-790

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported the trios traction vector was being used on a patient, with weight, and it came off the tower.

Manufacturer Narrative

The customer is setting up the traction vector differently than shown on section 9.1 of the owner's manual.Returned part meets specification.Tested up to 50lbs in the normal configuration and again per this facility's usual configuration and was unable to reproduce the problem.

Event Description

It was reported the trios traction vector was being used on a patient, with weight, and it came off the tower.

• Brand Name: CERVICAL TRACTION VECTOR ADJUSTER
• Type of Device: TRACTION ADJUSTER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 9330375
• MDR Text Key: 183885689
• Report Number: 2921578-2019-00045
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7803-790
• Device Catalogue Number: 7803-790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1