MAYFIELD® A1115Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® MODIFIED SWIVEL ADAPTOR · Class 1
- 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 10381780267782), received between Jan 8, 2026 and Jan 8, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
MalfunctionJan 8, 2026Detachment of Device or Device Component
A FACILITY REPORTED THAT THE MODIFIED SWIVEL ADAPTOR (A1115) CAME APART WHEN THE PATIENT WAS, BEING POSITIONED FOR A CRANIOTOMY PROCEDURE. THERE WAS A BRIEF DELAY UNTIL ANOTHER POSITIONER WAS FOUND AND REPLACED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24011581 ↗
Other Operating Room Accessories Table Tray devices
- MAYFIELD® A2101Integra Lifesciences Corporation · Operating Room Accessories Table Tray101 reports
- NA 210080Mako Surgical Corp. · Operating Room Accessories Table Tray74 reports
- ALLEN 104002Hill-Rom, Inc. · Operating Room Accessories Table Tray1 recall8 reports
- N/A 7210569Smith & Nephew, Inc. · Accessories, operating-room, table (kit)57 reports
- 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.