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

Model Number	113802-000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hfd100 skull clamp assembly has not yet been returned from the customer for evaluation.Once the device is received, it shall be evaluated and a follow-up report will be sent to fda.
Event or Problem Description
On (b)(6) 2016, three neurosurgeons were performing a tumor resection on a (b)(6) boy.At one point in the procedure, the surgeons thought they felt the patient's head shift due to movement on the double-pin side of the hfd100 fixation device.The surgeons worked together to verify that all points were tight and secure on the hfd, then continued with the case.There was no injury or adverse effect to the patient.The procedure was completed successfully with a full resection.
Additional Manufacturer Narrative
The initial adverse event report was submitted to fda on 12/23/2016.Once the skull clamp in question was received, it was evaluated.The device history record was reviewed and no discrepancies were noted.A mechanical evaluation of the skull clamp was performed and the device was found to be operating within specifications.We were unable to verify the complaint.The fact that the three surgeons verified that all points on the hfd were tight and secure and there was no adverse effect to the patient supports a conclusion that there was no device malfunction.
Event or Problem Description
On (b)(6) 2016, three neurosurgeons were performing a tumor resection on a (b)(6) year old patient.At one point in the procedure, the surgeons thought they felt the patient's head shift due to movement on the double-pin side of the hfd100 head fixation device.The surgeons worked together to verify that all points were tight and secure on the hfd, then continued with the case.There was no injury or adverse effect to the patient.The procedure was completed successfully with a full resection.At the time that the original mdr was submitted (12/23/2016), the head fixation device had not been returned for evaluation.This follow-up report provides the results of evaluation of the returned hfd skull clamp.

• Brand Name: HFD100 HEAD FIXATION DEVICE
• Common Device Name: SKULL CLAMP
• Manufacturer (Section D): IMRIS-DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• MDR Report Key: 6202824
• Report Number: 3010326005-2016-00006
• Device Sequence Number: 11006995
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: 00857534006011
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K103493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Inspection,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2017

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: Physician
• Device Model Number: 113802-000
• Device Catalogue Number: HFD100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2016
• Supplement Report FDA Received Date: 01/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 5 YR
• Patient Weight: 21