MAYFIELD® A2079Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® INFINITY XR2 BASE UNIT · 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 10381780267959), received between Apr 28, 2022 and Aug 22, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Unintended Movement1
- Vibration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Laceration(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2025Vibration; Vibration
THIS REPORT IS 2 OF 2 AND LINKED TO MFG REPORT NUMBER 3004608878-2025-00168: A FACILITY REPORTED THAT THE MAYFIELD INFINITY XR2 BASE UNIT (A2079) WAS USED IN A CRANIOTOMY PROCEDURE, AND WHILE THE PATIENT WAS DRAPED AND MICROSCOPE WAS IN USE, THE SURGEON FELT A VIBRATION. THEY CHECKED THE PATIENT, AND EVERYTHING APPEARED TO BE FINE. HOWEVER, THE PATIENT MOVED, AND THEY CHECKED AND SAW THAT THE BASE UNIT HAD MOVED AND THE PATIENT'S HEAD FELL OUT OF THE PINS CAUSING 2 LACERATIONS OF 1-2 INCHES TO THE BACK OF THE HEAD. TWO SEPARATE SURGICAL STAPLES WERE REQUIRED. THERE WAS NO DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DISCHARGED WITH NO NOTABLE PHYSICAL INJURY OTHER THAN THE 2 LACERATIONS.
Patient problems: Laceration(s)
MAUDE report 22878762 ↗MalfunctionJul 13, 2022Break; Break
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2022-00144: A FACILITY REPORTED THAT DURING AN UNSPECIFIED SURGERY, WHEN CLAMPING THE HEAD, THE LOCKING SCREW ON THE MAYFIELD SWIVEL ADAPTER THAT CONNECTS THE MAYFIELD INFINITY XR2 BASE UNIT (A2079) AND THE HEAD MOUNT BROKE. THE PATIENT'S HEAD WAS THUS FREELY MOVABLE AND WAS SECURED BY THE BEDDING ORDERLY TO AVOID INJURIES. NO SERIOUS CONSEQUENCES FOR THE PATIENT WERE OBSERVED. THE EVENT LED TO INCREASED SURGERY TIME OF 15 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15001205 ↗MalfunctionApr 28, 2022Unintended Movement; Unintended Movement
A FACILITY REPORTED THAT THE MAYFIELD INFINITY XR2 BASE UNIT (A2079) HAD TOO MUCH MOVEMENT. THE FACILITY HAS NOT REPORTED IF THERE WAS PATIENT INVOLVEMENT, INJURY OR SURGICAL DELAY RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14240054 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.