HFD100 119695-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857534006608), received between May 14, 2022 and May 14, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 8, 2025Open, Classified

   Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.

   Z-1034-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2022Unintended Movement; Unintended Movement

  A CUSTOMER REPORTED THAT THE FEMALE AND MALE SKULL CLAMP COMPONENTS OF THEIR HFD100 DEVICE APPEAR TO EXHIBIT SLIGHT MOVEMENT IN RELATION TO EACH OTHER AFTER BEING FIXED WITH THE LOCKING MECHANISM. THE CUSTOMER ALSO REPORTED THIS MOVEMENT COULD IMPACT THEIR LITT CASES. NO ADVERSE PATIENT CONSEQUENCES OR PROCEDURAL OUTCOMES HAVE BEEN REPORTED IN CONNECTION WITH THIS INFORMATION. FURTHER INFORMATION AND ACCESS TO THE SPECIFIC HFD100 DEVICE AND COMPONENTS IS BEING SOUGHT FROM THE CUSTOMER TO INVESTIGATE THE CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402887 ↗

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-0934-2022 · Feb 17, 2022 · Terminated
  Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used wi
• Z-3211-2017 · Aug 14, 2017 · Terminated
  IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw