Head Fixation Device HFD100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00857534006011), received between Dec 23, 2016 and Jan 10, 2025 — classified as 13 malfunctions.

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

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Break; Break

  A CUSTOMER REPORTED THE TORQUE SCREW COMPONENT OF THE HFD100 HEAD FIXATION DEVICE DID NOT FEEL SECURE WHEN PINNING THE PATIENT. THE SURGEON CONTINUED USE OF THE TORQUE SCREW AND THE HFD100 DEVICE, AND COMPLETED THE PLANNED PROCEDURE WITH THE DEVICE. THE CUSTOMER REPORTED NO PATIENT INJURY OCCURRED DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21132036 ↗
• MalfunctionDec 18, 2024Break; Break

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20972883 ↗
• MalfunctionDec 13, 2024Unstable; Unstable

  A CUSTOMER REPORTED THAT DURING AN RNS PLACEMENT PROCEDURE, THE HFD100 HEAD FIXATION DEVICE WAS UNSTABLE AND EXHIBITED PLAY, CAUSING THE NEED TO RE-PIN THE PATIENT THREE TIMES UNTIL THE PATIENT WAS SUCCESSFULLY PINNED WITHOUT PLAY OBSERVED IN THE DEVICE. THE CUSTOMER REPORTED NO INJURIES ASIDE FROM THE MULTIPLE EXTRA PIN SITES, AND A DELAY IN THE PROCEDURE OF APPROXIMATELY 60 MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PROBLEM WAS OBSERVED DURING PINNING PRIOR TO FIRST CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931431 ↗
• MalfunctionSep 19, 2024Unintended Movement; Unintended Movement

  DURING ROUTINE IMRIS PREVENTIVE MAINTENACE ON AN HFD100 HEAD FIXATION DEVICE, THE SERVICE ENGINEER OBSERVED APPROXIMATELY 3MM OF MOVEMENT AFTER THE ROCKER ARM LOCKING KNOB ON ONE OF THE SKULL CLAMP HALVES WAS LOCKED INTO PLACE. THERE WAS NO PATIENT INVOLVEMENT IN THIS FINDING, AND THE ASSEMBLY WAS TAGGED AND REMOVED FROM ONGOING USE BY CUSTOMER SITE STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261658 ↗
• MalfunctionFeb 20, 2023Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED THAT ON (B)(6) 2023, WE WERE DOING A CRANIOTOMY FOR A TUMOR RESECTION, AND WHILE USING THE HFD (PINS) ON A PATIENT, OUR PATIENT'S HEAD SLIPPED IN THE PINS. THE INITIAL PRESSURE WAS 50LBS, AND WHEN THE SLIP OCCURRED, DURING SURGERY, WHILE DRILLING OUT THE BONE FLAP, WE CHECKED AND IT HAD SLIPPED TO 20LBS. THE PATIENT WAS 120KG, SO NOT SURE IF THAT COULD HAVE BEEN A FACTOR. WE SWITCHED THE MAYFIELD AND PINS OUT UNDER THE DRAPES. FURTHER INFORMATION GATHERED FROM THE CUSTOMER REPORTED THAT POSITIONING THIS PATIENT WAS DIFFICULT DUE TO SIZE OF THE PATIENT AND ACHIEVING THE CORRECT AMOUNT OF FLEXION FOR THE HEAD WAS NOT EASY. THE PATIENT WAS RE-PINNED UNDERNEATH THE DRAPES USING A BACKUP HEAD FIXATION DEVICE. THE CUSTOMER REPORTED THEY WERE NOT ABLE TO DO THE IMRI SCAN AND ARE UNSURE IF PATIENT MOVED MUCH DURING SLIPPAGE AND THAT IS WHY THE PATIENT DIDN'T FIT IN THE SCANNER. IT WAS REPORTED THE CASE WAS COMPLETED AND THE PATIENT EXPERIENCED A SMALL LACERATION AT A PIN SITE ON THE SCALP THAT REQUIRED A SUTURE AT THE END OF THE CASE, AND THAT THE PATIENT LIKELY GOT A ROUTINE POST-OP SCAN. NO FURTHER INJURY OR IMPACT WAS REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 16401647 ↗
• MalfunctionFeb 4, 2022Decrease in Pressure; Decrease in Pressure

  ON (B)(6)2021, A PROCEDURE WAS BEING PERFORMED AND THE PATIENT WAS PINNED ON THE STRETCHER. WHEN THE PATIENT WAS FLIPPED ON THE OR TABLE INTO POSITION, THE HFD100 SKULL CLAMP SLIPPED OFF. AS A RESULT, THE PINS SCRATCHED THE PATIENTS HEAD CAUSING A MINOR LACERATION.THE SKULL CLAMP WAS ADJUSTED HOWEVER, IT SLIPPED A SECOND TIME. THE SKULL CLAMP WAS EXCHANGED BUT IT FAILED TO PROPERLY CLAMP ON THE FIRST TIME. A SECOND ATTEMPT WAS PERFORMED AND THE CLAMP WORKED AS NORMAL. THE SURGEON CONCLUDED THAT THE FIRST SKULL CLAMP MALFUNCTION AND THE SECOND SKULL CLAMP FIRST ATTEMPT FAILURE WERE CAUSED BY OPERATOR ERROR.THE SKULL CLAMPS AND ASSOCIATED TORQUE SCREWS WERE REPLACED AND RETURNED FOR FURTHER EVALUATION.

  Patient problems: Laceration(s)

  MAUDE report 13451190 ↗
• MalfunctionFeb 3, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  DURING A PATIENT PROCEDURE ON (B)(6) 2019, TWO NEUROSURGEONS NOTICED THE LOOSE FIT OF THE HFD100 SKULL CLAMP ASSEMBLY.THE PATIENT'S HEAD MOVED DURING DRILLING HOWEVER, THE PATIENT DID NOT SUSTAIN ANY INJURIES OTHER THAN SKIN DAMAGE.

  Patient problems: Skin Tears

  MAUDE report 13441555 ↗
• MalfunctionOct 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE FRAME OF THE HFD100 SLIPPED WHILE A PATIENT'S HEAD WAS PINNED. THE PATIENT WAS IN THE PRONE POSITION WITH 60 LBS OF PRESSURE EXERTED BY THE TORQUE SCREW, AND ALL JOINTS WERE REPORTED TO HAVE BEEN CHECKED BY TWO PEOPLE DURING PINNING AND CONFIRMED TO BE TIGHT. THE SLIPPAGE OCCURRED PRIOR TO ENTERING STERILE FIELD; THERE WAS NO NEGATIVE IMPACT OR CONSEQUENCE TO THE PATIENT OR PROCEDURE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12644511 ↗
• MalfunctionAug 5, 2021Device Slipped; Device Slipped

  THE SKULL CLAMP IN AN IMRIS HEAD FIXATION DEVICE WAS REPORTED TO SLIP DURING USE IN A PROCEDURE, WHICH CAUSED A 2-INCH LACERATION ON THE PATIENT'S SKULL.

  Patient problems: Laceration(s)

  MAUDE report 12278820 ↗
• MalfunctionSep 30, 2020Decrease in Pressure; Decrease in Pressure

  THE CUSTOMER STATED THAT DURING DAILY PREP, THE HEAD FIXATION DEVICE WAS SLIPPING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10605961 ↗
• MalfunctionFeb 22, 2018Device Operates Differently Than Expected

  THE HFD100 HEAD FIXATION DEVICE WAS BEING UTILIZED DURING A SURGICAL CASE AND AT SOME POINT INTRAOPERATIVELY, THE BRAINLAB NAVIGATION BECAME INACCURATE. THERE WAS NO EVIDENCE OF THE PATIENT SLIPPING IN THE SKULL PINS. THERE WERE NO INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7289802 ↗
• MalfunctionAug 16, 2017Detachment Of Device Component; Device Slipped

  DURING A SURGICAL PROCEDURE ON (B)(6) 2017, SLIPPAGE IN THE EXTENSION JOINTS/ LINKAGE OF THE HFD100 SKULL CLAMP ASSEMBLY OCCURRED. THIS CAUSED THE BREATHING CIRCUIT TO BECOME DETACHED. THE SURGICAL TEAM READJUSTED THE BREATHING CIRCUIT UNDER THE DRAPES. THE INCIDENT WAS CONSIDERED MAINLY AN INCONVENIENCE, THE PROCEDURE CONTINUED AFTER THE INCIDENT. THERE WERE NO INJURIES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6796769 ↗
• MalfunctionDec 23, 2016Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6202824 ↗

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