MAYFIELD® A2020Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® Radiolucent Disposable Adult Skull Pin (Sapphire) · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780025818), received between Jun 22, 2022 and Mar 22, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation2
- Fracture1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
- Skull Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2024Material Fragmentation; Material Fragmentation
InjuryDec 22, 2023Fracture; Fracture
A FACILITY REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE MAYFIELD RADIOLUCENT SKULL PINS (A2020) FRACTURED IN THE PATIENT'S HEAD. PATIENT WAS PINNED AND ONCE UNDER PRESSURE THEY SAW PATIENT BLEEDING AND NOTICED PIECE WAS BROKEN AND IN THE PIN SITE OF THE PATIENT'S SCALP. THE MAYFIELD DEVICE WAS REMOVED, REVEALING THAT THE RIGHT FRONTAL PIN HAD SPLINTERED, CAUSING A VERY SMALL LACERATION ON THE PIN SITE. THE SITE WAS IRRIGATED AND CLOSED WITH A SINGLE 4-0 VICRYL HORIZONTAL MATTRESS. THE PATIENT IS CURRENTLY HEALING. THERE WAS NO SURGICAL DELAY.
Patient problems: Skull Fracture
MAUDE report 18383777 ↗InjuryJun 22, 2022Material Fragmentation; Material Fragmentation
A FACILITY REPORTED THAT THE TIP ON THE MAYFIELD RADIOLUCENT SKULL PINS (A2020) SPLINTERED AND BROKE OFF IN THE PATIENT'S SCALP, AND THE SURGEON NEEDED TO EXPLORE THE SCALP TO FIND THE LOST PIECE. THE INCIDENT OCCURRED WHEN THE PINS WERE BEING REMOVED AT THE END OF CRANIOTOMY PROCEDURE; THIS CAUSED QUITE A BIT OF BLEEDING WHICH ENDED UP MAKING THE CASE GO LONGER FOR 20 MINUTES.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14776837 ↗
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
- HFD100 119695-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
- DORO® Easy-Connect Navigation Adaptor 1204.002Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.