MAYFIELD® A2009Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® ULTRA 360 BASE UNIT · Class 1
All models of MAYFIELD (32)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10381780267850), received between Jul 17, 2021 and Aug 6, 2026 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Slipped11
- Unstable3
- Mechanical Problem2
- Mechanics Altered1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Unstable
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160846 ↗MalfunctionFeb 6, 2025Unstable; Unstable
A FACILITY REPORTED THAT THE MAYFIELD ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) DOES NOT HOLD POSITION. THE ISSUE WAS DETECTED DURING THE INTERVENTION, BUT THE PROCEDURE CONCLUDED REGULARLY, AND THE SURGERY WAS PERFORMED WITH THE SAME DEVICE, SINCE THEY NOTICED THE DEFECT ALMOST AT THE END OF THE SURGERY. THERE WAS NO INCREASED SURGERY TIME AND NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21322837 ↗MalfunctionJan 3, 2025Unstable; Unstable
MalfunctionNov 2, 2023Device Slipped; Device Slipped
MalfunctionNov 2, 2023Device Slipped; Device Slipped
MalfunctionMar 3, 2023Device Slipped; Device Slipped
MalfunctionDec 22, 2022Device Slipped; Device Slipped
A FACILITY REPORTED THAT THE ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) SLIPS WHEN LOCKED (EXTRUSION OF SHOCK CUSHION ON UPPER LOCKING ARM). NO INFORMATION HAS BEEN PROVIDED ON PATIENT INVOLVEMENT, INJURY, OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16040393 ↗MalfunctionAug 31, 2022Device Slipped; Device Slipped
A FACILITY REPORTED THAT THE ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) SLIPPED. THE FACILITY HAS NOT REPORTED IF THERE WAS PATIENT INVOLVEMENT, INJURY, OR SURGICAL DELAY RELATIVE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15329263 ↗MalfunctionJul 18, 2022Device Slipped; Mechanics Altered; Device Slipped; Mechanics Altered
A FACILITY REPORTED SLIPPAGE DURING AN UNSPECIFIED PROCEDURE, AND THAT THE TOP LOCKING HANDLE ON THE MAYFIELD ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) SEEMED A LITTLE LOOSE. IT IS UNKNOWN IF THERE WAS PATIENT INJURY. NO SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15041460 ↗MalfunctionJun 29, 2022Device Slipped; Device Slipped
A FACILITY REPORTED THAT THE ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) TOLERANCES ARE OFF AND SLIPPING. THE FACILITY HAS NOT REPORTED IF THERE WAS PATIENT INVOLVEMENT, INJURY OR SURGICAL DELAY RELATIVE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14861701 ↗MalfunctionJun 7, 2022Device Slipped; Device Slipped
THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00117 AND 3004608878-2022-00118. A FACILITY REPORTED THAT THE MAYFIELD ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) SLIPPED WHEN PATIENT'S HEAD WAS SECURED IN IT. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14627934 ↗MalfunctionJun 7, 2022Device Slipped; Device Slipped
IT WAS REPORTED THAT THE TOLERANCES ON THE MAYFIELD ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) WAS OFF AND THE UNIT WAS SLIPPING. THE FACILITY HAS NOT REPORTED IF THERE WAS PATIENT INVOLVEMENT, INJURY OR SURGICAL DELAY RELATIVE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14627930 ↗MalfunctionJun 7, 2022Device Slipped; Device Slipped
THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00117 3004608878-2022-00121 A FACILITY REPORTED THAT THE MAYFIELD ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) SLIPPED WHEN PATIENT'S HEAD WAS SECURED IN IT. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14627728 ↗MalfunctionJun 7, 2022Device Slipped; Device Slipped
THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00118, 3004608878-2022-00121. A FACILITY REPORTED THAT THE MAYFIELD ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) SLIPPED WHEN PATIENT'S HEAD WAS SECURED IN IT. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14627727 ↗MalfunctionAug 6, 2021Mechanical Problem; Mechanical Problem
A FACILITY REPORTED THAT THE LATCH CLOSEST TO THE HEAD ON THE ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) WAS NOT AS TIGHT AS IT SHOULD BE. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY IN STARTING CASE, AS IT WAS DISCOVERED DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12291491 ↗MalfunctionJul 17, 2021Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement
A FACILITY REPORTED THAT THE TOP LOCKING HANDLE ON THE ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) WOULD NOT LOCK; IT MOVES EVEN WHEN LOCKED AND THE GOLD LOCKING HANDLE WAS VERY LOOSE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT HOWEVER; NO PATIENT INJURY WAS REPORTED OR SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12186176 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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