MAYFIELD® A1064Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® BALL SOCKET SWIVEL ADAPTOR · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780267591), received between Mar 28, 2024 and Mar 7, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unstable” (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
- Unstable2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2025Unstable; Unstable
A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1064) IS MOBILE WHEN IT SHOULD NOT BE - TIGHTENING PROBLEM. THE ISSUE WAS NOTED BEFORE SURGERY WHILE THE PATIENT WAS UNDER ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21548458 ↗MalfunctionMar 28, 2024Unstable; Unstable
THIS REPORT IS 3 OF 3 LINKED TO MFG REPORT NUMBERS: 3004608878-2024-00039, 3004608878-2024-00040. A FACILITY REPORTED THAT THERE WAS AN ISSUE (MOVEMENT) WITH THE MAYFIELD BALL SOCKET SWIVEL ADAPTOR (A1064) DURING CRANIOTOMY SURGERY. THE PATIENT WAS ALREADY UNDER ANESTHESIA WHEN THE DYSFUNCTION WAS OBSERVED; HOWEVER, THERE WAS NO CONSEQUENCES/IMPACT FOR THE PATIENT. THE SURGERY WAS FINALIZED USING A REPLACEMENT UNIT WITH APPROXIMATELY 5 TO 10 MINUTES INCREASED SURGERY TIME (TIME TO FIND ANOTHER SKULL CLAMP). THE ONLY BIOGRAPHIC INFORMATION RECEIVED IS THAT THE PATIENT WAS AN ADULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18994946 ↗
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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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