MAYFIELD® A1012Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10381780267461), received between May 28, 2021 and Jul 31, 2025 — classified as 3 injuries, 3 malfunctions.

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680264 ↗
• InjuryJul 21, 2025Unstable; Unstable

  THIS IS 2 OF 4 REPORTS FOR THE MAYFIELD SYSTEM LINKED TO MFG REPORT NUMBERS: 3004608878-2025-00148, 3004608878-2025-00150, 3004608878-2025-00151. A FACILITY REPORTED THAT THE MAYFIELD SWIVEL HORSESHOE HEADREST (A1012) NEEDS TO BE CHECKED AS IT GOT LOOSE/BECAME UNLOCKED DURING SURGERY, RESULTING IN WHIPLASH FOR THE PATIENT. IT IS UNCLEAR IF THE EVENT LED TO INCREASED SURGERY TIME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Neck Stiffness

  MAUDE report 22555441 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 1 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2024-00107 3004608878-2024-00108 3004608878-2024-00109. A FACILITY REPORTED THAT FOUR INCIDENCES OF PRESSURE INJURY OCCURRED AFTER USING THE MAYFIELD SWIVEL HORSESHOE HEADREST (A1012) AND THE MAYFIELD PEDIATRIC HORSESHOE HEADREST (A1051). IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY; HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONALLY, THE FACILITY HAS INDICATED THERE WAS NO MALFUNCTION OF THE DEVICE AND IS PERFORMING A MULTIFACTORIAL ROOT CAUSE ANALYSIS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20153886 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 3 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2024-00106 3004608878-2024-00107 3004608878-2024-00109. A FACILITY REPORTED THAT FOUR INCIDENCES OF PRESSURE INJURY OCCURRED AFTER USING THE MAYFIELD SWIVEL HORSESHOE HEADREST (A1012) AND THE MAYFIELD PEDIATRIC HORSESHOE HEADREST (A1051). IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY; HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONALLY, THE FACILITY HAS INDICATED THERE WAS NO MALFUNCTION OF THE DEVICE AND IS PERFORMING A MULTIFACTORIAL ROOT CAUSE ANALYSIS.

  Patient problems: Spinal Cord Injury

  MAUDE report 20153885 ↗
• MalfunctionSep 7, 2023Device Slipped; Device Slipped

  A FACILITY REPORTED THAT THE MAYFIELD SWIVEL HORSESHOE HEADREST (A1012) WAS ¿SLIPPING¿. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17705223 ↗
• MalfunctionMay 28, 2021Mechanical Problem; Mechanical Problem

  A FACILITY REPORTED THAT PRIOR TO POSTERIOR CERVICAL DISCECTOMY, IT WAS DISCOVERED THAT THE MAYFIELD SWIVEL HORSESHOE HEADREST (A1012) HAD BAD THREADS AND WOULD NOT CONNECT TO THE MAYFIELD SWIVEL UNIT. THERE WAS A DELAY FOR ABOUT 30 MINUTES WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900967 ↗