HFD100

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.

Description of Event or Problem

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.