MAYFIELD® A2101Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® ULTRA BASE UNIT · Class 1
Quick summary
This Mayfield Ultra Base Unit is an operating-room accessory table tray. Reports mostly describe mechanical loosening or slipping during surgery, sometimes causing lacerations, abrasions, or bleeding. There are 98 adverse event reports, no deaths, 14 injuries, and 84 malfunctions. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 101
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 10381780267997), received between Sep 18, 2020 and Sep 28, 2026 — classified as 14 injuries, 87 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (33 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
- Mechanical Problem33
- Device Slipped21
- Mechanics Altered17
- Unstable13
- Physical Resistance/Sticking5
- Unintended Movement5
- Mechanical Jam3
- Naturally Worn3
Patient problems
- No Clinical Signs, Symptoms or Conditions84
- Laceration(s)6
- Insufficient Information4
- Abrasion3
- Hemorrhage/Blood Loss/Bleeding1
- Neck Stiffness1
- No Known Impact Or Consequence To Patient1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Unstable
A facility reported that the Mayfield Ultra Base Unit (A2101) would not maintain the head position. The issue was identified at the beginning of the procedure after the patient had been placed under anesthesia. As a result, the surgical procedure was prolonged by more than 30 minutes. No patient injury or adverse clinical outcome was reported. A replacement device was obtained and used to successfully complete the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915625 ↗MalfunctionSep 28, 2026Failure to Align
A facility reported that the pin on the Mayfield Ultra Base Unit (A2101) could not be inserted, preventing attachment of the connecting block. The issue was identified at the beginning of the procedure after the patient had been placed under anesthesia. As a result, the surgical procedure was prolonged by more than 30 minutes. No patient injury or adverse clinical outcome was reported. A replacement device was obtained and used to successfully complete the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915624 ↗MalfunctionAug 21, 2026Mechanics Altered; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50380990 ↗MalfunctionAug 11, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216691 ↗MalfunctionMay 8, 2026Unstable
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2026-00055: A FACILITY REPORTED THAT DURING SURGERY, THE MAYFIELD ULTRA BASE UNIT (A2101) LOOSENED TWICE WHILE DRILLING INTO THE PATIENT¿S SKULL. THE ISSUE OCCURRED INTRAOPERATIVELY, WHILE THE DEVICE WAS IN USE TO SECURE THE PATIENT¿S HEAD. THE MAYFIELD CLAMP WAS RETAINED AS THE SURGERY WAS ALREADY UNDERWAY, AND THE SURGICAL PROCEDURE WAS COMPLETED WITHOUT CHANGING THE DEVICE. THERE WAS NO INJURY OR INCREASED SURGERY TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125801 ↗MalfunctionMay 1, 2026Device Slipped
A FACILITY REPORTED THAT AFTER PATIENT WAS POSITIONED PRONE USING THE MAYFIELD HEAD HOLDER, A SLIGHT DOWNWARD SLIP OCCURRED. THE SURGICAL TEAM CONFIRMED THAT THE SLIP DID NOT OCCUR WITHIN THE MAYFIELD CLAMP, AND THE MAYFIELD ULTRA BASE (A2101), IS SUSPECTED TO HAVE CAUSED THE SLIP. A SIMILAR SLIP OCCURRED 2 WEEKS PRIOR, AND ALL OF THE HEAD HOLDERS WERE INSPECTED, BUT NO DEFECTS WERE FOUND AT THE TIME OF INSPECTION. AFTER THE SECOND OCCURRENCE, IT WAS FOUND THAT COUPLE OF BOLTS ON THE BASE MIGHT NOT BE TIGHTENED TO SPECIFICATIONS. NO INJURY OCCURRED AND NO INFORMATION ON SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25060277 ↗InjuryMar 14, 2026Unstable
THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2026-00007 AND 3004608878-2026-00031: A FACILITY REPORTED THAT THE MAYFIELD ULTRA BASE UNIT (A2101) CAME LOOSE DURING SURGERY, RESULTING IN A SINGLE SCRATCH TO THE PATIENT'S HAIRLINE/FOREHEAD, AND A BANDAGE WAS APPLIED TO THE FOREHEAD. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THE SURGERY TIME WAS NOT SIGNIFICANTLY INCREASED.
Patient problems: Abrasion
MAUDE report 24599763 ↗MalfunctionMar 9, 2026Device Slipped
THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS 3004608878-2026-00026 AND 3004608878-2026-00027: A FACILITY REPORTED THAT THE MAYFIELD ULTRA BASE UNIT (A2101) WAS PART OF A CERVICAL STABILIZATION CASE WHERE THE PHYSICIAN STATED THAT THE ENTIRE SYSTEM FELT LIKE IT SLIPPED. THE PROCEDURE WAS COMPLETED PER USUAL WITH NO INJURY TO THE PATIENT, WHO IS RECOVERING AS EXPECTED. ADDITIONALLY, THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24549058 ↗MalfunctionFeb 27, 2026Device Slipped
A FACILITY REPORTED THAT AFTER THE PATIENT WAS POSITIONED PRONE USING THE MAYFIELD HEAD HOLDER, AND A SLIGHT DOWNWARD SLIP OCCURRED. THE SURGICAL TEAM CONFIRMED THAT THE SLIP DID NOT OCCUR WITHIN THE MAYFIELD CLAMP, AND THE MAYFIELD ULTRA BASE UNIT (A2101) IS SUSPECTED TO HAVE CAUSED THE SLIP. IT IS SUSPECTED THAT COUPLE OF BOLTS ON THE BASE MIGHT NOT BE TIGHTENED TO SPECIFICATIONS. THERE WAS NO PATIENT INJURY AND SURGICAL DELAY IS UNKNOWN. ADDITIONAL INFORMATION IS BEING REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24476952 ↗InjuryFeb 20, 2026Device Slipped
THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS 3004608878-2026-00017 AND 3004608878-2026-00019: A FACILITY REPORTED THAT THE PATIENT WAS IN THE PRONE POSITION FOR A CRANIOTOMY PROCEDURE AND SLIPPED FROM THE MAYFIELD ULTRA BASE UNIT (A2101). THIS RESULTED IN AN INCH AND A HALF DEEP LACERATION TO THE PATIENT'S LEFT SCALP WHICH REQUIRED SUTURING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Laceration(s)
MAUDE report 24405450 ↗InjuryFeb 12, 2026Unstable
MalfunctionJan 29, 2026Unstable
A FACILITY REPORTED THAT AT THE BEGINNING OF SURGERY IN A PATIENT WITH SPHENOIDAL MENINGIOMA, THE INTERMEDIARY PART (TRANSITIONAL MEMBER) OF THE MAYFIELD ULTRA BASE UNIT (A2101) BECAME LOOSE. THE PATIENT'S HEAD WAS NO LONGER PROPERLY FIXED/ATTACHED, AND THE OPERATING POSITION HAD BEEN CHANGED. THERE WERE NO OTHER CONSEQUENCE FOR THE PATIENT. HOWEVER, THERE COULD HAVE BEEN A RISK/A WRONG OPERATING "MOVE" IF IT WOULD HAVE OCCURRED DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209620 ↗MalfunctionDec 12, 2025Mechanics Altered; Mechanics Altered
MalfunctionDec 12, 2025Mechanics Altered; Mechanics Altered
MalfunctionNov 26, 2025Device Slipped; Device Slipped
MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPORTED THAT THE MAYFIELD ULTRA BASE UNIT (A2101) WAS BENT AND DOES NOT FIT IN THE OPERATING TABLE FIXTURE. THE PATIENT WAS ASLEEP UNDER ANESTHESIA; HOWEVER, THERE WAS NO PATIENT INJURY. ANOTHER MAYFIELD WAS USED AND THERE WAS INCREASED SURGERY TIME OF 30 MINUTES DUE TO THE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605664 ↗InjuryJul 21, 2025Unstable; Unstable
THIS IS 4 OF 4 REPORTS FOR THE MAYFIELD SYSTEM LINKED TO MFG REPORT NUMBERS: 3004608878-2025-00148, 3004608878-2025-00149, 3004608878-2025-00151. A FACILITY REPORTED THAT THE MAYFIELD ULTRA BASE UNIT (A2101) 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 22555449 ↗MalfunctionJun 20, 2025Mechanics Altered; Mechanics Altered
AN AUTHORIZED DISTRIBUTOR REPORTED THAT DURING THE OPERATION, THE MAYFIELD ULTRA BASE UNIT (A2101) DID NOT MAINTAIN CORRECT TIGHTENING. SURGERY TIME WAS INCREASED FOR MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY. END USER HOSPITAL: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22296947 ↗MalfunctionJun 20, 2025Device Slipped; Device Slipped
A FACILITY REPORTED THAT A PATIENT SLIPPED WHILE THE MAYFIELD ULTRA BASE UNIT (A2101) WAS BEING SET UP, AND THE GOLD HANDLE WAS FOUND TO BE LOOSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22296945 ↗MalfunctionJun 10, 2025Unstable; Unstable
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2025-00121: A FACILITY REPORTED THE MAYFIELD ULTRA BASE UNIT (A2101) DOES NOT CLOSE WELL AND MOVES EVEN WHEN LOCKED. THE PATIENT WAS ASLEEP, AND THERE WAS INCREASED SURGERY TIME IN BEGINNING THE SURGERY. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22180013 ↗MalfunctionMay 21, 2025Mechanics Altered; Mechanics Altered
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2025-00108: A FACILITY REPORTED THAT THE MAYFIELD ULTRA BASE UNIT (A2101) WAS USED IN A CASE, AND THE JOINT COULD NOT HOLD. AS A RESULT, THE DEVICE WAS CHANGED. THERE WAS NO PATIENT INJURY; HOWEVER, THERE WAS SIGNIFICANT INCREASED SURGICAL TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22060296 ↗MalfunctionApr 24, 2025Unstable; Unstable
THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS 3004608878-2025-00080 AND 3004608878-2025-00081: A FACILITY REPORTED THAT ONCE FIXED, THE MAYFIELD ULTRA BASE UNIT (A2101) WAS NOT STABLE. THE PROBLEM WAS FOUND ON THE PATIENT UNDER ANESTHESIA, BEFORE THE SURGERY. SINCE THE PATIENT COULD NOT GIVE UP THIS SURGERY, WE MINIMIZED THE MOVEMENT OF THE HEADBOARD AS MUCH AS POSSIBLE, TAKING INTO ACCOUNT ITS IMPERFECT STABILITY FOR THE ENTIRE DURATION OF THE SURGERY. THERE WAS NO INCREASED SURGERY TIME OR PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21901683 ↗MalfunctionApr 3, 2025Unstable; Unstable
MalfunctionMar 20, 2025Degraded; Degraded
MalfunctionMar 13, 2025Unstable; Unstable
THIS REPORT IS 3 OF 3 AND LINKED TO MFG REPORT NUMBERS 3004608878-2025-00044 AND 3004608878-2025-00049: A FACILITY REPORTED THAT THE MAYFIELD ULTRA BASE UNIT (A2101) IS MOBILE WHEN IT SHOULD NOT BE - TIGHTENING PROBLEM. THE ISSUE WAS NOTED BEFORE SURGERY WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WAS NO PATIENT INJURY AND NO INCREASED SURGERY TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21602011 ↗
Other Operating Room Accessories Table Tray devices
- 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
- MAYFIELD® A3101Integra Lifesciences Corporation · Operating Room Accessories Table Tray34 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.