MAYFIELD® A3018Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® CS Swivel Adaptor · Class 1
- 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 10381780268147), received between Dec 13, 2024 and Mar 13, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (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
- Device Slipped2
- Unstable1
Patient problems
- Insufficient Information1
- 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.
InjuryMar 13, 2025Device Slipped; Device Slipped
THIS REPORT IS 3 OF 3 AND IS LINKED TO MFG REPORT NUMBERS 3004608878-2025-00046 AND 3004608878-2025-00047: A FACILITY REPORTED THAT DURING A CHIARI REPAIR CASE, THE MAYFIELD COMPOSITE SERIES SWIVEL ADAPTOR (A3018) SLIPPED ON THE PATIENT'S SKULL DESPITE ALL THREE PINS APPEARING FULLY LOCKED IN PLACE. LACERATIONS OCCURRED ON BOTH SIDES OF PATIENT'S SKULL AND REQUIRED STAPLING. THE MAYFIELD SET UP WAS REMOVED AND REPLACED WITH AN ALTERNATIVE KIT, AND THE SURGEON PROCEEDED WITH THE OPERATION. THERE WAS SURGICAL DELAY OF APPROXIMATELY 20 MINUTES.
Patient problems: Laceration(s)
MAUDE report 21599444 ↗MalfunctionDec 17, 2024Device Slipped; Device Slipped
MalfunctionDec 13, 2024Unstable; Unstable
A FACILITY REPORTED THAT THE PATIENT'S HEAD MOVED IN THE MAYFIELD COMPOSITE SERIES SWIVEL ADAPTOR, STANDARD (A3018). NO INFORMATION HAS BEEN PROVIDED ON PATIENT INVOLVEMENT, INJURY, OR SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20921924 ↗
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- ALLEN 107004Hill-Rom, Inc. · Operating Room Accessories Table Tray1 recall5 reports
- ALLEN 108001Hill-Rom, Inc. · Operating Room Accessories Table Tray1 recall3 reports
- NA 7210551Smith & Nephew, Inc. · Accessories, operating-room, table (kit)41 reports
- MAYFIELD® A1018Integra Lifesciences Corporation · Operating Room Accessories Table Tray36 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.