MAYFIELD® A1117Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® MR/X-RAY SKULL CLAMP WITH EXCITE 3.0T ADAPTOR · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780253600), received between Jun 3, 2022 and Dec 12, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Slipped1
- Mechanics Altered1
Patient problems
- Increased Respiratory Rate1
- Laceration(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2025Device Slipped; Device Slipped
MalfunctionNov 9, 2022Break; Break
A FACILITY REPORTED THAT BROKEN PARTS OF THE MAYFIELD SKULL CLAMP (A1117) WAS DISCOVERED DURING AN UNSPECIFIED SURGICAL PROCEDURE - PATIENT WAS UNDER ANESTHESIA. THE MEDICAL STAFF FINISHED THE SURGERY BY CLOSING PUNCTUALLY THE PATIENT'S WOUND (SURGICAL SITE) TO RE-POSITION THE PATIENT IN THE SKULL CLAMP. AS A RESULT, THERE WAS INFECTIOUS RISK TO THE PATIENT. THERE WAS INCREASED SURGERY TIME OF 4+ HOURS DUE TO THE REPOSITIONING OF THE PATIENT IN THE HEADREST, RE-MATCHING OF THE NEURONAVIGATION, RESHAPING AND RESUMPTION OF SURGICAL ACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15764062 ↗InjuryJun 3, 2022Mechanics Altered; Mechanics Altered
A FACILITY REPORTED THAT DURING USE OF THE MAYFIELD SKULL CLAMP (A1117), THE HEAD OF THE PATIENT SLIPPED DURING SURGERY CAUSING A LACERATION. THEY STOPPED THE SURGERY TO SUTURE THE LACERATION. FACILITY ALSO INDICATED THAT THE FORCE APPLIED DO NOT MATCH TO THE FORCE INDICATED (PRESSURE ISSUE). NO INCREASED SURGERY TIME WAS REPORTED.
Patient problems: Laceration(s)
MAUDE report 14593849 ↗
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.