MAUDE Adverse Event Report: MIZUHO CORPORATION MULTIPURPOSE HEAD FRAME; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Model Number	07-951-00MM
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This product was used to immobilize the patient's head during a brain tumor removal surgery; however, the joints of the head holder could not be fully secured.
Additional Manufacturer Narrative
Investigation including review of manufacturing records, dimensional measurements, and fitting tests confirmed the product met specifications with no issues.In combination testing with the table attachment, slight movement within specification limits was observed but did not affect use.Warnings in the instruction for use advise users to ensure all joints are securely fixed before use and to check for deformation or abnormal movement.

• Brand Name: MULTIPURPOSE HEAD FRAME
• Common Device Name: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): MIZUHO CORPORATION; 3-30-13 hongo; bunkyo-ku; tokyo, 113-0 033,; JA 113-0033,
• Manufacturer Contact: 3-30-13 hongo; bunkyo-ku; tokyo, 113-0-033
• MDR Report Key: 22639793
• Report Number: 3011547624-2025-00003
• Device Sequence Number: 9695405
• Product Code: HBL
• UDI-Device Identifier: 04946329272956
• UDI-Public: (01)04946329272956(10)VK
• Combination Product (Y/N): N
• PMA/510(K) Number: K821772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: 07-951-00MM
• Device Catalogue Number: 07-951-00MM
• Device Lot Number: VK
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2023
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 17-952-00 TABLE ATTACHMENT.
• Patient Sex: Male