MAUDE Adverse Event Report: MIZUHO OSI CERVICAL TRACTION VECTOR ADJUSTER; OPERATING TABLE

Model Number	7803-790
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was having a posterior cervical fusion using gardner wells tongs and trios vector traction.Trios vector traction slipped mid case and patients head fell and was caught by the horseshoe headrest.Patient was not injured.
Event or Problem Description
Patient was having a posterior cervical fusion using gardner wells tongs and trios vector traction.Trios vector traction slipped mid case and patients head fell and was caught by the horseshoe headrest.Patient was not injured.
Additional Manufacturer Narrative
Based on the information obtained following the evaluation of the device, it was concluded that the aging of the bumper (clamping component of the device) seemed to affect the integrity of the device surface thus causing in the slipping motion.It was also observed that the device was not subjected to regular inspection to check the wear and perform cleaning prior to the use despite being mentioned in the owner's manual as the following warning- "before and after each use, inspect the table top, components and accessories for possible damage, excessive wear or non-functioning parts.Carefully inspect all critical accessible areas, joints and all moving parts for possible damage and non-function.Damaged or defective parts should not be used or processed".Thus, prolong use of the device without regular inspection and maintenance may also have affected the bumper integrity causing the slipping motion.

• Brand Name: CERVICAL TRACTION VECTOR ADJUSTER
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 16677760
• Report Number: 2921578-2023-00003
• Device Sequence Number: 6539362
• Product Code: JEA
• UDI-Device Identifier: 00842430111679
• UDI-Public: 00842430111679
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown