MAYFIELD® A1059Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® Modified Skull Clamp · Class 2
Quick summary
This Integra Mayfield skull clamp is a head holder used in neurosurgery, and its 506 reports often describe the clamp slipping, loosening, or moving during surgery. Some reports describe cuts to the scalp after the clamp slipped, and one says it detached during surgery. There are no deaths and 174 injuries reported, and no recalls name this device. Reports fell to 45 in the past year from 94 in the year before.
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
- 506
- Deaths reported
- 0
- Injuries reported
- 172
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 506 adverse event reports that list this exact device (DI 10381780253457), received between Apr 5, 2019 and Sep 29, 2026 — classified as 172 injuries, 334 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (156 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
- Device Slipped156
- Mechanics Altered91
- Unstable86
- Mechanical Problem79
- Unintended Movement62
- Adverse Event Without Identified Device or Use Problem18
- Break4
- Difficult to Open or Close4
Patient problems
- No Clinical Signs, Symptoms or Conditions308
- Laceration(s)127
- Insufficient Information39
- Unspecified Tissue Injury24
- Abrasion7
- Hemorrhage/Blood Loss/Bleeding3
- Needle Stick/Puncture3
- Skull Fracture2
Recent adverse event reports
The 25 most recent of 506 reports, 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 11, 2026Unstable
Patient problems: Insufficient Information
MAUDE report 50735547 ↗MalfunctionAug 6, 2026Unstable
Patient problems: Insufficient Information
MAUDE report 50160168 ↗MalfunctionJul 14, 2026Unstable
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25814058 ↗MalfunctionJun 4, 2026Device Slipped
A FACILITY REPORTED THAT THERE WAS A PATIENT SLIP INVOLVING THE MAYFIELD MODIFIED SKULL CLAMP (A1059). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25395103 ↗MalfunctionJun 4, 2026Device Slipped
A FACILITY REPORTED THAT THE SURGEON PLACED THE MAYFIELD MODIFIED SKULL CLAMP (A1059) ON THE PATIENT, BUT WHEN APPLYING THE PRESSURE SCREW, THE RATCHET SEEMED TO SLIP. THE SURGEON DECIDED TO SWITCH OUT THE SKULL CLAMP AS A PRECAUTION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25394693 ↗InjuryMay 22, 2026Device Slipped
A FACILITY REPORTED THAT SURGEON WAS PERFORMING A C7-T1 DECOMPRESSION AND FUSION WITH THE PATIENT IN THE PRONE POSITION IN THE MAYFIELD MODIFIED SKULL CLAMP (A1059), AND AT THE END OF THE CASE, BLOOD WAS NOTICED UNDER THE DRAPE. THE SURGEON LOOKED UNDER THE DRAPE AND ACCESSED THAT THE SKULL CLAMP HAD SLIPPED WHICH RESULTED IN A SMALL LACERATION THAT WAS CLOSED WITH STAPLES. THE PATIENT WAS REPORTED AS STABLE.
Patient problems: Laceration(s)
MAUDE report 25262699 ↗MalfunctionMay 15, 2026Unstable
AN AUTHORIZED DISTRIBUTOR REPORTED THAT THE MAYFIELD HEAD CLAMP (A1059) WAS FOUND TO BE TOO LOOSE AND DETACHED FROM THE PATIENT DURING SURGERY AT GREAT WESTERN HOSPITAL NHS FOUNDATION TRUST. NO INJURY WAS SUSTAINED AS THE SURGEON IMMEDIATELY NOTICED THE PIN CAME LOOSE. THE UNIT WAS FIXED AND RE-TIGHTENED AND THE SURGERY PROCEEDED AS PLANNED. NO ADDITIONAL COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185782 ↗InjuryMay 1, 2026Mechanics Altered
A FACILITY REPORTED THAT DURING A POSTERIOR CERVICAL FUSION PROCEDURE, THE LOCKING MECHANISM OF THE MAYFIELD MODIFIED SKULL CLAMP (A1059) DID NOT ENGAGE WHICH CAUSED A SCALP LACERATION TO THE PATIENT REQUIRING STICHES TO CLOSE THE LACERATION. THERE WAS NO SURGICAL DELAY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2026.
Patient problems: Laceration(s)
MAUDE report 25060758 ↗MalfunctionMay 1, 2026Device Slipped
A FACILITY REPORTED THAT THE MAYFIELD MODIFIED SKULL CLAMP (A1059) SLIPPED DURING USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25060278 ↗MalfunctionApr 24, 2026Difficult to Open or Close; Physical Resistance/Sticking
A FACILITY REPORTED THAT THE C LOCK ON THE MAYFIELD MODIFIED SKULL CLAMP (A1059) IS STICKING, HARD TO LOOSEN, AND WHEN LOCKED ON THE PATIENT¿S HEAD IS HARD TO UNLOCK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24984932 ↗MalfunctionApr 24, 2026Device Slipped
THE FACILITY REPORTED THAT THE LOANER MAYFIELD MODIFIED SKULL CLAMP (A1059P) SLIPPED WITH THE PATIENT ATTACHED. NO INFORMATION ON DELAY IN PROCEDURE OR PATIENT INJURY HAS BEEN MADE AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 24982933 ↗InjuryMar 30, 2026Device Slipped
InjuryMar 20, 2026Device Slipped
InjuryMar 20, 2026Device Slipped; Adverse Event Without Identified Device or Use Problem
A FACILITY REPORTED THAT DURING SHIFT IN POSITIONING IN THE MAYFIELD MODIFIED SKULL CLAMP (A1059), THE PATIENT SUFFERED HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Laceration(s); Unspecified Tissue Injury
MAUDE report 24649971 ↗MalfunctionMar 13, 2026Mechanics Altered
A FACILITY REPORTED THAT THE MAYFIELD MODIFIED SKULL CLAMP (A1059) HAS A DEFECT AND COULD NOT BE LOCKED/ LOOSENED EVEN AFTER SEVERAL ATTEMPTS WHILE THE PATIENT¿S HEAD WAS FIXED IN PLACE. THE CLAMP WAS REPLACED WITH ANOTHER MAYFIELD CLAMP. THERE WAS NO INCREASED SURGERY TIME AND NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24597420 ↗InjuryMar 13, 2026Unstable
MalfunctionMar 9, 2026Mechanics Altered
A FACILITY REPORTED THAT THE PATIENT WAS UNDER ANESTHESIA AND HIS HEAD WAS ALREADY CLAMPED IN THE MAYFIELD MODIFIED SKULL CLAMP (B)(6), BUT THE CLAMP COULD NOT BE LOCKED. THE LOCK MECHANISM IS UNRELIABLE, STIFF, AND JAMS OCCASIONALLY, RESULTING IN INADEQUATE PATIENT HEAD FIXATION. THERE WAS NO SURGICAL DELAY OR PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551623 ↗MalfunctionMar 9, 2026Device Slipped
THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS 3004608878-2026-00025 AND 3004608878-2026-00027: A FACILITY REPORTED THAT THE MAYFIELD SKULL CLAMP (A1059) 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 24549078 ↗MalfunctionMar 9, 2026Mechanical Jam
MalfunctionMar 6, 2026Device Slipped
MalfunctionFeb 27, 2026Unstable
A FACILITY REPORTED THAT PREOPERATIVELY, THE MAYFIELD MODIFIED SKULL CLAMP (A1059) WAS NOT SECURE ENOUGH AND CAME LOOSE. THE MEDICAL STAFF COMPLETED THE PROCEDURE WITH ANOTHER MAYFIELD. THE SURGERY TIME WAS INCREASED BY APPROXIMATELY 30 MINUTES; HOWEVER, THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24476948 ↗InjuryFeb 20, 2026Device Slipped
THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS 3004608878-2026-00017 AND 3004608878-2026-00018: A FACILITY REPORTED THAT THE PATIENT WAS IN THE PRONE POSITION FOR A CRANIOTOMY PROCEDURE AND SLIPPED FROM THE MAYFIELD MODIFIED SKULL CLAMP (A1059). 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 24405304 ↗InjuryFeb 13, 2026Device Slipped
A FACILITY REPORTED THAT DURING "C1-C2 LAMINECTOMY FOR CERVICAL SC S TRIAL (PERCUTANEOUS LEADS) WITH CREATION OF RIGHT FLANK IPG POCKET WITH IOM" PROCEDURE, THE PIN OF THE MAYFIELD MODIFIED SKULL CLAMP (A1059) CAME LOOSE AND SLIPPED CAUSING LACERATION TO THE PATIENT WHICH REQUIRED CLEANING AND CLOSURE WITH STAPLES. THERE WAS NO SURGICAL DELAY, AND THE PATIENT WAS REPORTED TO BE HEALING WELL WITH NO RESIDUAL ISSUES.
Patient problems: Laceration(s)
MAUDE report 24333505 ↗InjuryFeb 13, 2026Detachment of Device or Device Component
A FACILITY REPORTED THAT THE PLUNGER OF THE MAYFIELD MODIFIED SKULL CLAMP (A1059) FELL OUT DURING A CASE RESULTING IN LACERATION TO THE PATIENT WHICH REQUIRED STAPLES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Laceration(s)
MAUDE report 24333090 ↗
Other HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) devices
- MAYFIELD® A3059Integra Lifesciences Corporation · HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)196 reports
- DORO® Skull Clamp 1001.001Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)173 reports
- Head Fixation Device HFD100IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall13 reports
- HFD100 119629-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall6 reports
- DORO® Skull Clamp 3003-009Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)52 reports
- HFD100 119695-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
- DORO® Easy-Connect Navigation Adaptor 1204.002Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
- HFD100 119630-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.