MAYFIELD® A1011Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® HORSESHOE HEADREST · Class 1
Data updated Oct 13, 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 10381780267430), received between May 5, 2023 and May 5, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Open or Close” (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.
Most reported problems
Device problems
- Difficult to Open or Close1
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.
MalfunctionMay 5, 2023Difficult to Open or Close; Difficult to Open or Close
Other HEADREST, NEUROSURGICAL devices
- NA Head SupportSteris Corporation · HEADREST, NEUROSURGICAL1 recall5 reports
- NA Head SupportSteris Corporation · HEADREST, NEUROSURGICAL1 recall1 report
- MAYFIELD® A1012Integra Lifesciences Corporation · HEADREST, NEUROSURGICAL6 reports
- MAYFIELD® A1051Integra Lifesciences Corporation · HEADREST, NEUROSURGICAL5 reports
- DORO® Base Unit 3001-00Black Forest Medical GmbH · Headrest, Neurosurgical3 reports
- DORO® Adaptor 3002-00Black Forest Medical GmbH · Headrest, Neurosurgical2 reports
- MAYFIELD® A1112Integra Lifesciences Corporation · HEADREST, NEUROSURGICAL1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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