Radiolucent Head Frame 07-986-07Recalls & reported problems
Mizuho Corporation · Head Pin, (Radiolucent, Carbon 2) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04946329237344), received between Mar 19, 2025 and Mar 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
THIS DEVICE IS A SURGICAL INSTRUMENT USED TO HOLD THE CRANIUM IN PLACE DURING SURGERY. IT CONSISTS OF A TIP THAT IS INSERTED INTO THE PATIENT'S CRANIUM AND A BODY PART IN ONE PIECE. THREE OF THESE DEVICES WERE USED TO HOLD THE PATIENT'S CRANIUM IN PLACE DURING A NEUROSURGICAL PROCEDURE. AFTER THE SURGERY, WHEN THE HOSPITAL STAFF ATTEMPTED TO REMOVE THEM FROM THE PATIENT'S HEAD, THE CONNECTION BETWEEN THE TIP OF THE DEVICE AND THE MAIN BODY LOOSENED ON TWO OF THE THREE PIECES, CAUSING THE REMOVAL TO TAKE LONGER THAN USUAL. THE OCCURRENCE OF THIS EVENT PROLONGED THE ANESTHESIA TIME. THERE WERE NO RESIDUALS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21645167 ↗
Other Holder, Head, Neurosurgical (Skull Clamp) devices
- MAYFIELD® A1059Integra Lifesciences Corporation · HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)506 reports
- MAYFIELD® A3059Integra Lifesciences Corporation · HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)196 reports
- DORO® Skull Clamp 1001.001Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)173 reports
- Head Fixation Device HFD100IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall13 reports
- HFD100 119629-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall6 reports
- DORO® Skull Clamp 3003-009Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)52 reports
- DORO® Easy-Connect Navigation Adaptor 1204.002Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
- HFD100 119695-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page