MAYFIELDRecalls & reported problems across all models
Integra Lifesciences Corporation · 32 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,082
- Deaths reported
- 0
- Injuries reported
- 327
- Recalls
- 0
We found 32 models of MAYFIELD by Integra Lifesciences Corporation in the FDA's device registry (GUDID). Together they are named in 1,082 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2019 and Sep 29, 2026 — classified as 327 injuries, 753 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (355 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MAYFIELD problems
Device problems
- Device Slipped355
- Mechanical Problem182
- Unstable172
- Mechanics Altered143
- Unintended Movement141
- Adverse Event Without Identified Device or Use Problem34
- Physical Resistance/Sticking17
- Break13
Patient problems
- No Clinical Signs, Symptoms or Conditions702
- Laceration(s)241
- Insufficient Information71
- Unspecified Tissue Injury32
- Abrasion15
- Hemorrhage/Blood Loss/Bleeding7
- Skull Fracture5
- Neck Stiffness4
MAYFIELD models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MAYFIELD® A1059HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)506 reports
- MAYFIELD® A3059HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)196 reports
- MAYFIELD® A2101Operating Room Accessories Table Tray101 reports
- MAYFIELD® A1108HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)39 reports
- MAYFIELD® A2114HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)39 reports
- MAYFIELD® A1114HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)36 reports
- MAYFIELD® A1018Operating Room Accessories Table Tray36 reports
- MAYFIELD® A3101Operating Room Accessories Table Tray34 reports
- MAYFIELD® A2000HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)30 reports
- MAYFIELD® A2009Operating Room Accessories Table Tray16 reports
- MAYFIELD® A1114AHOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)6 reports
- MAYFIELD® A1012HEADREST, NEUROSURGICAL6 reports
- MAYFIELD® A1051HEADREST, NEUROSURGICAL5 reports
- MAYFIELD® A2600MOperating Room Accessories Table Tray4 reports
- MAYFIELD® A2020HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)3 reports
- MAYFIELD® A1117HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)3 reports
- MAYFIELD® A2079Operating Room Accessories Table Tray3 reports
- MAYFIELD® A3018Operating Room Accessories Table Tray3 reports
- MAYFIELD® A1083HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)2 reports
- MAYFIELD® A1064Operating Room Accessories Table Tray2 reports
- MAYFIELD® R6367AORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- MAYFIELD® R6398AORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- MAYFIELD® A1084HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)1 report
- MAYFIELD® 439A1092HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)1 report
- MAYFIELD® A1059PHOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)1 report
- MAYFIELD® A1120HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)1 report
- MAYFIELD® A1011HEADREST, NEUROSURGICAL1 report
- MAYFIELD® A1112HEADREST, NEUROSURGICAL1 report
- MAYFIELD® A1113Operating Room Accessories Table Tray1 report
- MAYFIELD® A1115Operating Room Accessories Table Tray1 report
- MAYFIELD® A2101POperating Room Accessories Table Tray1 report
- MAYFIELD® A3100Operating Room Accessories Table Tray1 report
Recent MAYFIELD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931973 ↗MalfunctionSep 28, 2026Unstable
Patient problems: Insufficient Information
MAUDE report 50916232 ↗MalfunctionSep 28, 2026Unstable
This is 1 of 2 reports linked to MFG Report Number (b)(4):A facility reported that the Mayfield 2 Base Unit, Standard (A3101) became loose during a procedure. Additional information has been requested.
Patient problems: Insufficient Information
MAUDE report 50916231 ↗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 ↗MalfunctionSep 11, 2026Unstable
Patient problems: Insufficient Information
MAUDE report 50735547 ↗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 ↗MalfunctionAug 6, 2026Unstable
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160846 ↗MalfunctionAug 6, 2026Unstable
Patient problems: Insufficient Information
MAUDE report 50160168 ↗OtherJul 27, 2026Device Slipped
Patient problems: Laceration(s)
MAUDE report 50026001 ↗MalfunctionJul 27, 2026Unstable
OtherJul 27, 2026Device Slipped
A facility reported that the Mayfield Skull Clamp (Unknown Catalog#) slipped, and the skull pin scraped the patient's skull, causing an injury to the patient. Additional information has been requested.
Patient problems: Abrasion
MAUDE report 50025485 ↗MalfunctionJul 14, 2026Unstable
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25814058 ↗InjuryJun 18, 2026Unstable
A FACILITY REPORTED THAT THE TWO PIN ROCKER ARM OF THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) MOVED WHILE IN LOCKED POSITION RESULTING IN PATIENT INJURY.
Patient problems: Unspecified Tissue Injury
MAUDE report 25553863 ↗
Other Integra Lifesciences Corporation products
All Integra Lifesciences Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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