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	03/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that traction vector popped off tower in the middle of a cervical case.The surgeon applied the vector himself and uses this attachment frequently.The patient was not injured.
Event or Problem Description
Customer reported that traction vector popped off tower in the middle of a cervical case.The surgeon applied the vector himself and uses this attachment frequently.The patient was not injured.
Additional Manufacturer Narrative
Returned device failed to hold in load test according to specification.Failure was due to material condition changed (rubber mounts got harder).Bumper is made of rubber and its condition will change over time depending on temperature, usage, cleaning solutions.

• 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: 11602149
• Report Number: 2921578-2021-00009
• Device Sequence Number: 4455270
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• 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: 04/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/01/2021
• 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