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

Model Number	7803-790
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a brand-new traction vector connected to 15 lbs of weight and gw tongs attached to patient's head popped off upper tower of trios table during a post cervical procedure.
Additional Manufacturer Narrative
Rubber component showed early hardening and wear.After one month of use this device would no longer pass a load test.
Event or Problem Description
It was reported a brand-new traction vector connected to 15 lbs of weight and gw tongs attached to patient's head popped off upper tower of trios table during a post cervical procedure.

• Brand Name: CERVICAL TRACTION VECTOR ADJUSTER
• Common Device Name: TRACTION SYSTEM
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 11733719
• Report Number: 2921578-2021-00014
• Device Sequence Number: 14508237
• Product Code: JEA
• UDI-Device Identifier: 00842430111679
• UDI-Public: 00842430111679
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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: 05/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2021
• Supplement Date Received by Manufacturer: 02/21/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1