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

Model Number	07-986-07
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This device is a surgical instrument used to hold the cranium in place during surgery.It consists of a tip that is inserted into the patient's cranium and a body part in one piece.Three of these devices were used to hold the patient's cranium in place during a neurosurgical procedure.After the surgery, when the hospital staff attempted to remove them from the patient's head, the connection between the tip of the device and the main body loosened on two of the three pieces, causing the removal to take longer than usual.The occurrence of this event prolonged the anesthesia time.There were no residuals to the patient.
Additional Manufacturer Narrative
The product was reviewed and found to have no manufacturing issues.It functioned as intended upon inspection.It is a single-piece design, not intended to be disassembled.The user mistakenly believed the tip could be detached.The returned item showed damage such as protruding pins, wear marks, and tool-related deformation.These signs suggest improper handling, not a product defect.The user has been informed.
Event or Problem Description
This device is a surgical instrument used to hold the cranium in place during surgery.It consists of a tip that is inserted into the patient's cranium and a body part in one piece.Three of these devices were used to hold the patient's cranium in place during a neurosurgical procedure.After the surgery, when the hospital staff attempted to remove them from the patient's head, the connection between the tip of the device and the main body loosened on two of the three pieces, causing the removal to take longer than usual.The occurrence of this event prolonged the anesthesia time.There were no residuals to the patient.

• Brand Name: RADIOLUCENT HEAD FRAME
• Common Device Name: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): MIZUHO CORPORATION; 3-30-13 hongo; bunkyo-ku; tokyo, 11300 33; JA 1130033
• MDR Report Key: 21645167
• Report Number: 1000159388-2025-00001
• Device Sequence Number: 7564753
• Product Code: HBL
• UDI-Device Identifier: 04946329237344
• UDI-Public: 0104946329237344
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025
• Report Date (Section F): 03/19/2025

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: 07-986-07
• Device Catalogue Number: 07-986-07
• Device Lot Number: TG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/18/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 08/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/19/2025