MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. HEAD FIXATION DEVICE HFD100; SKULL CLAMP

Model Number	HFD100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The torque screw component is replaced as part of standard preventive maintenance; the torque screw at issue had been in use for approximately 3 months at the date of the event.Further investigation and device analysis is in process and a follow-up mdr will be submitted after investigation is complete.
Event or Problem Description
A customer reported that a neurosurgeon identified a small crack in the housing of a torque screw during use with a hfd100 head fixation device when pinning the skull in a semi-supine position for tumor resection.The surgeon elected to continue use of the torque screw instead of re-pinning, and no procedural complications or patient impact was reported.Post-operatively upon removal of the torque screw the housing cracked further.It was reported there was no patient injury or impact to the planned procedure.Patient demographic information was sought but not provided.
Additional Manufacturer Narrative
Investigation confirmed the torque screw component was manufactured within specification, however the mechanical design of the component may contribute to cracking in the threaded housing component of the torque screw.The manufacturer has initiated corrective and preventive action to further address this issue.This report also encompasses udi related data quality updates to match brand name and udi with gudid data.

• Brand Name: HEAD FIXATION DEVICE HFD100
• Common Device Name: SKULL CLAMP
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: paul campbell ; 1230 chaska creek way; suite 100; chaska, MN 55318
• MDR Report Key: 20972883
• Report Number: 3010326005-2024-00015
• Device Sequence Number: 18293210
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: (01)00857534006011(11)20151026
• Combination Product (Y/N): N
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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: HFD100
• Device Catalogue Number: 113803-000
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2015
• 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