MAUDE Adverse Event Report: IMRIS IMAGING, INC. HFD100; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Model Number	119629-000
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skull Fracture (2077)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The imris cse went on site and inspected the hfd100 device.No issues were found or reported.The device had passed preventative maintenance approximately three months prior to this event.The entire head fixation device, including the torque screws, linkages, and head frame was inspected and no discrepancies or functional issues were identified.Based on clinical assessment of known information, functional assessment of subject device, and communications with the end user, the probable cause of the fractures is related to poor condition of the patient's anatomy and/or suboptimal device placement.A follow-up report will be submitted if any additional information becomes available.
Event or Problem Description
It was reported a minor injury occurred while pinning a six (6) year old patient using the hfd100 device during a craniotomy.Details of event were provided by a nurse via email on november 6, 2025.The nurse observed the skull clamp was tightened by the surgeon who immediately noticed a loss of pressure.The surgeon theorized the clamp (part of the hfd100) may be broken or the patient has a fracture due to a thin skull.A ct of the patient's head was conducted while under anesthesia, which added an additional 30 minutes to the overall or time, and small bilateral skull factures were seen.It was reported the skull fractures did not require intervention.The neurosurgeon used the horseshoe headrest in the supine position to complete the craniotomy, and the procedure was completed successfully.Imris followed up with the customer, who indicated the pressure applied to skull was 45 pounds.It was further confirmed the patient had fractures on both sides of the skull.

• Brand Name: HFD100
• Common Device Name: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): IMRIS IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55319
• Manufacturer (Section G): IMRIS IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: stacy kramer ; 1230 chaska creek way; suite 100; chaska, MN 55318
• MDR Report Key: 23723010
• Report Number: 3010326005-2025-00006
• Device Sequence Number: 8421077
• Product Code: HBL
• UDI-Device Identifier: 00857534006592
• UDI-Public: (01)00857534006592(11)20220829
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K103493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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?: No
• Device Model Number: 119629-000
• 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: 11/06/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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 Age: 6 YR
• Patient Sex: Male