Disposable Radiolucent Skull Pins (3 Pcs) 18910-01ARecalls & reported problems
Brainlab SE · 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 04056481004767), received between May 30, 2018 and May 30, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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.
Most reported problems
Device problems
- Failure To Adhere Or Bond1
- Use of Device Problem1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2018Failure To Adhere Or Bond; Use of Device Problem; Failure To Adhere Or Bond; Use of Device Problem
A PATIENT WAS FIXATED IN THE PMI DORO RADIOLUCENT SKULL CLAMP USING BRAINLAB RADIOLUCENT PINS DURING A CRANIAL PROCEDURE (A TRANSMASTOID CRANIOTOMY FOR RESECTION OF AN ENDOLYMPHATIC SAC TUMOR). THE SURGEON EXPERIENCED DIFFICULTIES IN PLACING THE PINS, ESP. TO VERIFY THAT THE PIN TIPS WERE IN COMPLETE CONTACT WITH THE SKULL, DUE TO A SIGNIFICANT AMOUNT OF FAT IN THE SUBCUTANEOUS LAYER OF THE PATIENT'S SCALP. SEVERAL TABLE MANEUVERS WERE PERFORMED TO CONFIRM THAT THERE WAS NO MOVEMENT OF THE PATIENT HEAD, AND STABILITY OF THE FIXATION WAS DETERMINED SATISFACTORY FOR THE PROCEDURE. DURING THE CASE, AFTER APPROX. 7H, WHILE THE SURGICAL RESECTION CAVITY WAS BEING INSPECTED FOR ADDITIONAL TUMOR (SURGEON WAS INSIDE WITH FORCEPS, AND CRITICAL BRAIN STRUCTURES WERE EXPOSED), THE PATIENT HEAD JERKED IN A SINGLE, RAPID MOVEMENT. THE HEAD SLIPPED OUT OF THE TWO PINS ON THE FOREHEAD. THIS CAUSED A LACERATION OF 1-2 CM ON THE RIGHT HAND SIDE WHICH NEEDED STITCHES, THE PUNCTURE ON THE LEFT HAND SIDE WAS LARGER THAN USUAL BUT DID NOT REQUIRE STITCHES. THE PATIENT HEAD COULD BE STABILIZED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ACCORDING TO THE HOSPITAL, THE SURGERY WAS COMPLETED SUCCESSFULLY,
Patient problems: Laceration(s)
MAUDE report 7552512 ↗
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