HFD100 119629-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00857534006592), received between Nov 1, 2021 and Dec 4, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K103493); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 17, 2022Terminated

   Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.

   Z-0934-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  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.

  Patient problems: Skull Fracture

  MAUDE report 23723010 ↗
• MalfunctionOct 9, 2024Break; Break

  A CUSTOMER REPORTED THAT THE TORQUE SCREW OF AN HFD100 HEAD FIXATION DEVICE BROKE AS THE TORQUE SCREW WAS BEING ADVANCED THROUGH THE THREADS OF THE HFD100. THE BREAK WAS REPORTED TO OCCUR IMMEDIATELY UPON INSERTING THE TORQUE SCREW WITH LITTLE PRESSURE BEING APPLIED. THE PROCEDURE WAS COMPLETED BY USING A SECOND AVAILABLE TORQUE SCREW. NO DELAY OR IMPACT TO THE PATIENT OR PROCEDURE WAS REPORTED; THE PATIENT WAS REPORTED TO BE STABLE AND THE PROCEDURE WAS REPORTED TO BE SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413016 ↗
• MalfunctionApr 5, 2023Unstable; Unstable

  THE CUSTOMER REPORTED THE HEAD HOLDER FOR OPERATIONS ASSEMBLY IS TOO LOOSE, AND THAT DURING SET UP OF THE EQUIPMENT FOR THE HFD100 HEAD FIXATION DEVICE, THE LINKAGE WAS LOOSE/WOBBLY AND WAS REPLACED PRIOR TO A LITT PROCEDURE. THE CUSTOMER REPORTED THE PATIENT DID NOT SUSTAIN INJURY DUE TO THE EQUIPMENT ISSUE, AND THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 5-10 MINUTES WHILE THE LINKAGE COMPONENTS OF THE SUBJECT HFD100 WERE SWAPPED OUT FOR LINKAGE COMPONENTS FROM AN ALTERNATE HFD100 AT THE CUSTOMER SITE. THE CUSTOMER REPORTED THERE WAS NO SIGNIFICANT DELAY OR IMPACT ON THE PROCEDURE AND THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686624 ↗
• MalfunctionJun 1, 2022Break; Break

  A CUSTOMER REPORTED THAT A TORQUE SCREW IN USE WITH AN HFD100 HEAD FIXATION DEVICE BROKE APART DURING PINNING AS PRESSURE WAS BEING APPLIED. THE CUSTOMER REPORTED NO INJURY TO THE PATIENT OCCURRED. A SECOND TORQUE SCREW WAS THEN USED IN THE HFD100 DEVICE, AFTER WHICH THE SURGICAL PROCEDURE PROCEEDED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569826 ↗
• MalfunctionFeb 4, 2022Unintended Movement; Unintended Movement

  DURING A PEDIATRIC PROCEDURE ON (B)(6) 2020, THE CUSTOMER REPORTED THAT THE HFD100 SKULL CLAMP SLIPPED. THERE WAS NO PATIENT HARM REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13451139 ↗
• MalfunctionNov 1, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A HEAD FIXATION DEVICE (HFD) EXHIBITED TOO MUCH PLAY DURING SET UP PRIOR TO PINNING THE PATIENT DURING A PROCEDURE. THE NEUROSURGEON DECIDED NOT TO USE THE DEVICE IN THE PROCEDURE; NO IMPACT TO THE PATIENT OR PROCEDURE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725915 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103493. One submission often covers many models, so check the product and lot details in each record.

• Z-1034-2026 · Dec 8, 2025 · Open, Classified
  Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Versi
• Z-3211-2017 · Aug 14, 2017 · Terminated
  IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw