MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. ASSY, SWIVEL ADAPTER; MEDICAL TABLE CLAMP

Model Number	5979-323
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a supine acdf procedure on a trios table, the locking knob of the swivel adapter that interfaces with the skull clamp was detached, causing the patient's head to drop a few inches on the imaging top pad.No injury reported to the patient.Neuromonitoring indicated everything was normal.
Additional Manufacturer Narrative
Per the information obtained during the investigation, the end cap of the swivel adapter came unglued and fell out.There is no other available fastening mechanism to screw the end cap back onto the device.While the information pertaining to the lot and serial number of the swivel adapter and the tablebase respectively was not obtained, the age of the main cervical management unit that the swivel adapter is part of was found to be 10+ years (mfg date- 08/26/2010).The product design life is 10 years as per the owner's manual and hence the root cause of the end cap of the swivel adapter is suspected to be wear and tear/excessive use beyond the product lifetime.
Event or Problem Description
During a supine acdf procedure on a trios table, the locking knob of the swivel adapter that interfaces with the skull clamp was detached, causing the patient's head to drop a few inches on the imaging top pad.No injury reported to the patient.Neuromonitoring indicated everything was normal.

• Brand Name: ASSY, SWIVEL ADAPTER
• Common Device Name: MEDICAL TABLE CLAMP
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 21366381
• Report Number: 2921578-2025-00001
• Device Sequence Number: 8590312
• Product Code: JEA
• UDI-Device Identifier: 00842430113888
• UDI-Public: (01)00842430113888
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5979-323
• Device Catalogue Number: 5979-323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown