MAYFIELD® A3059Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® 2 Skull Clamp · Class 2
Quick summary
This Integra Mayfield skull clamp, used to hold the head during surgery, has 196 reports, 61 injuries and no deaths. Many reports describe the clamp slipping or moving after it was locked, leading to lacerations and pin-site skin damage, and some describe delays while it was replaced. No recalls name this device. Reports fell from 50 in the prior 12 months to 19 in the most recent 12 months.
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
- 196
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 196 adverse event reports that list this exact device (DI 10381780253792), received between Mar 12, 2021 and Sep 28, 2026 — classified as 58 injuries, 136 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (77 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 Slipped77
- Unintended Movement46
- Unstable33
- Mechanical Problem25
- Mechanics Altered16
- Adverse Event Without Identified Device or Use Problem3
- Physical Resistance/Sticking3
- Noise, Audible2
Patient problems
- No Clinical Signs, Symptoms or Conditions127
- Laceration(s)54
- Insufficient Information12
- Unspecified Tissue Injury4
- Abrasion1
- Hyperextension1
Recent adverse event reports
The 25 most recent of 196 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Unstable
Patient problems: Insufficient Information
MAUDE report 50916232 ↗OtherJul 27, 2026Device Slipped
Patient problems: Laceration(s)
MAUDE report 50026001 ↗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 ↗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 ↗MalfunctionMay 22, 2026Unstable
A FACILITY REPORTED THAT DURING A CASE OF SCOLIOSIS, THE PATIENT¿S HEAD MOVED IN THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059), AND THE PATIENT¿S NOSE WAS NO LONGER IN THE SAME PLACE COMPARED TO THE SUPPORT. NO INFORMATION ON PATIENT INJURY OR SURGICAL DELAY HAS BEEN RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25262700 ↗InjuryMay 15, 2026Unstable
THE FACILITY REPORTED THAT DURING "STEREOTACTIC PLACEMENT OF LASER PROBES; LASER ABLATION OF RIGHT AMYGDALA AND HIPPOCAMPUS; LASER ABLATION OF PERIVENTRICULAR HETEROTOPIA PROCEDURE", THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) DISENGAGED CAUSING A LACERATION TO THE PATIENT. PER SURGEON'S OPERATIVE NOTE, THE MAYFIELD RELEASED PRIOR TO INITIATING REGISTRATION RESULTING IN A 3CM LACERATION THAT WAS PREPPED AND STAPLED TO REPAIR. THERE WAS A 15 MINUTE SURGICAL DELAY. THE PATIENT IS NOW DISCHARGED.
Patient problems: Laceration(s)
MAUDE report 25185778 ↗MalfunctionMay 15, 2026Unstable
A FACILITY REPORTED THAT DURING PATIENT PREPARATION UNDER ANESTHESIA, A DEFECT WAS IDENTIFIED IN THE MAYFIELD COMPOSITE SERIES CLAMP (A1059) WHICH AFFECTED THE LOCKING MECHANISM ON THE SIDE PINS. THE ISSUE WAS DETECTED AFTER THE DEVICE HAD ALREADY BEEN APPLIED TO THE PATIENT. DUE TO THE MALFUNCTION, THE CLAMP HAD TO BE REMOVED AND REPLACED WITH ANOTHER DEVICE, RESULTING IN A DELAY OF APPROXIMATELY 10 MINUTES. ALTHOUGH NO SERIOUS INJURY OCCURRED, THE PATIENT SUSTAINED UNNECESSARY MINOR WOUNDS CAUSED BY THE PINS DURING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185774 ↗MalfunctionMay 1, 2026Unstable
A FACILITY REPORTED THAT THE SURGEONS FELT THAT MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) WAS SHIFTING WHEN BEGINNING TO OPERATE DUE TO THE LOCKING MECHANISM. HOWEVER, UPON INSPECTION, THE LOCK WAS FULLY ENGAGED, AND THE PRESSURE SETTING WAS BETWEEN THE RECOMMENDED SETTING 3-4 AND DID NOT CHANGE DURING POSITIONING/INTRA-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25060276 ↗MalfunctionMar 9, 2026Device Slipped
A FACILITY REPORTED THAT MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) WAS USED FOR A C3-C5 POSTERIOR CERVICAL FUSION AND DECOMPRESSION, AND THE SWIVEL LOCK DID NOT ENGAGE LEADING TO A SLIP. ANOTHER MAYFIELD TONG WAS BROUGHT INTO THE ROOM AND THE PATIENT'S HEAD WAS SECURED WITHOUT SLIPPING. THERE WAS A 5¿10-MINUTE DELAY IN STARTING THE SURGERY WHICH WENT AS PLANNED WITHOUT COMPLICATIONS FROM THE SLIPPING OF THE MAYFIELD TONGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24552692 ↗MalfunctionFeb 13, 2026Device Slipped
InjuryJan 8, 2026Device Slipped
A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A1059) WAS USED FOR A "CRANIOTOMY FOR TUMOR RESECTION" PROCEDURE, AND THE PATIENT'S HEAD SLIPPED SLIGHTLY WHEN POSITIONING. THIS RESULTED IN A 3CM SCALP LACERATION FROM THE PINS SLIPPING, WHICH WAS STAPLED. THERE WAS A DELAY OF 10 MINUTES; HOWEVER, THE TUMOR RESECTION WAS COMPLETED.
Patient problems: Laceration(s)
MAUDE report 24012618 ↗MalfunctionJan 8, 2026Unstable
A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) CAME LOOSE DURING SURGERY. THE SURGERY WAS COMPLETED WITH THE AFFECTED DEVICE. THERE WAS NO PATIENT INJURY, AND IT IS UNKNOWN IF THERE WAS INCREASED SURGICAL TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24012612 ↗MalfunctionJan 2, 2026Unstable
A FACILITY REPORTED THAT DURING "C2-7 POSTERIOR CERVICAL LAMINECTOMY AND FUSION" PROCEDURE, THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) UNLOCKED WHILE FLIPPING THE PATIENT TO PRONE POSITION. THE PROCEDURE WAS COMPLETED AS PER USUAL, BUT THE TEAM HAD TO BE CAUTIOUS AND VIGILANT ON PATIENT POSITIONING THROUGHOUT THE PROCEDURE. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943833 ↗MalfunctionDec 18, 2025Mechanics Altered; Mechanics Altered
A FACILITY REPORTED THAT THE SWIVEL ARM LOCKING MECHANISM ON THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) WAS DEFECTIVE DURING CLAMPING / FIXING AND DURING THE SURGERY. THERE WAS NO PATIENT INJURY OR INCREASED SURGERY TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23845503 ↗InjuryDec 12, 2025Device Slipped; Device Slipped
A FACILITY REPORTED THAT THE ROCKER ARM SIDE OF THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) DID NOT LOCK, AND THE PATIENT SLIPPED WHICH RESULTED IN INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Unspecified Tissue Injury
MAUDE report 23796698 ↗MalfunctionDec 12, 2025Unstable; Unstable
InjuryNov 13, 2025Unstable; Unstable
A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) LOST TENSION EITHER DURING THE CASE OR WHILE PINNING AND PATIENT INJURY RESULTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED RELATED TO TYPE OF INJURY AND SURGICAL DELAY.
Patient problems: Unspecified Tissue Injury
MAUDE report 23544289 ↗InjuryNov 6, 2025Device Slipped; Device Slipped
A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) WAS USED IN A POSTERIOR CERVICAL PROCEDURE, AND THE PATIENT EXPERIENCED A SLIP. AS A RESULT, THE PATIENT SUSTAINED LACERATIONS TO THE SKIN, AND THERE WAS SURGICAL DELAY DUE TO THE NEED TO REMOVE THE PATIENT FROM THE POSITIONING DEVICE AND CHANGE THE POSITIONING EQUIPMENT. HOWEVER, THE PATIENT HAS SINCE BEEN DISCHARGED WITH NO COMPLICATIONS THAT IS DIRECTLY LINKED TO THE INCIDENT.
Patient problems: Laceration(s)
MAUDE report 23490846 ↗InjuryNov 6, 2025Unstable; Unstable
MalfunctionOct 31, 2025Unstable; Unstable
A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) WAS LOOSE AFTER BEING LOCKED INTO POSITION ON THE PATIENT. ANOTHER CLAMP WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437419 ↗InjuryOct 24, 2025Device Slipped; Device Slipped
A FACILITY REPORTED THAT WHILE POSITIONING AND LOCKING THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) FOR AN ARTERIOVENOUS MALFORMATION (AVM) PROCEDURE, THE PATIENT'S HEAD SLIPPED RESULTING IN LACERATIONS TO THE SKIN THAT REQUIRED STAPLES. THE PATIENT IS STABLE WITH NO INJURY OTHER THAN THE SKIN LACERATION. THERE WAS MINIMAL DELAY OF 10 MINUTES.
Patient problems: Laceration(s)
MAUDE report 23384935 ↗MalfunctionOct 24, 2025Unstable; Unstable
MalfunctionOct 21, 2025Device Slipped; Device Slipped
MalfunctionOct 17, 2025Device Slipped; Device Slipped
A FACILITY REPORTED THAT DURING A CASE, THE PATIENT'S HEAD SLIPPED IN THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) WHILE THE SCREW WAS BEING PLACED. THE SURGEON VERIFIED THAT ALL PARTS WERE TIGHTENED AND LOCKED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: 1. ANY OTHER PERTINENT DETAILS OF THE INCIDENT? ANSWER: IN MIDDLE OF THE CASE, SURGEON WAS PLACING A CERVICAL SCREW, FELT THE PATIENT SHIFT TO ONE DIRECTION AND THEN BACK TO ORIGINAL POSITION WHEN SCREW WAS GOING IN. 2. WHAT TYPE OF PROCEDURE/SURGERY WAS PERFORMED DURING THE INCIDENT? ANSWER: CERVICAL SPINE POSTERIOR FUSION C/NAVIGATION: OCCIPITAL - C6 FUSION C/C3-C5 LAMINECTOMY 3. WAS THERE A DELAY IN SURGERY DUE TO PRODUCT PROBLEM? IF YES, HOW LONG IN MINUTES? ANSWER: YES, APPROXIMATELY 7 MINUTES OF DELAY TIME, DUE TO A SURGEON SCRUBBING OUT TO ASSIST TEAM LEAD IN DOUBLE CHECKING THE EQUIPMENT, MAKING SURE ALL POINTS WERE SECURED. 4. WHEN PLACING THE SKULL CLAMP, IF YOU WERE TO DRAW AN IMAGINARY LINE BETWEEN THE SINGLE PIN AND THE ROCKER ARM SWIVEL POINT, DID THAT IMAGINARY LINE PASS THROUGH AN AXIAL CENTER OF THE SKULL? ANSWER: YES 5. DID EACH PIN ENGAGE THE CRANIUM IN A PERPENDICULAR APPROACH?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23325135 ↗MalfunctionSep 11, 2025Unstable; Unstable
A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) LOST TENSION EITHER DURING THE CASE OR WHILE PINNING. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT DID HAVE STRUCTURAL ABNORMALITIES THAT COULD HAVE AIDED IN THE MALFUNCTION. NO INFORMATION HAS BEEN PROVIDED ON PATIENT INJURY OR SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 23029880 ↗
Other HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) devices
- MAYFIELD® A1059Integra Lifesciences Corporation · HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)506 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.