MAYFIELD® A1114Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® INFINITY SKULL CLAMP · Class 2
Quick summary
This Integra Mayfield Infinity skull clamp is a surgical head holder that pins the patient's head to keep it steady during brain and spine operations. The 35 reports mostly describe the clamp slipping, shifting, or releasing on its own while the patient was still pinned, sometimes jamming or changing pressure so the patient moved and suffered cuts needing stitches. There are 13 injuries and no deaths. 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
- 36
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10381780253549), received between Mar 26, 2019 and Jul 27, 2026 — classified as 13 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (11 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 Slipped11
- Mechanical Problem10
- Unstable8
- Mechanical Jam4
- Unintended Movement3
- Insufficient Device Problem Information1
- Mechanics Altered1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Laceration(s)11
- Unspecified Tissue Injury3
- No Consequences Or Impact To Patient2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Unstable
MalfunctionDec 29, 2025Unstable; Unstable
InjuryDec 5, 2025Unstable; Unstable
InjuryMay 1, 2025Unstable; Unstable
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2025-00088: A FACILITY REPORTED THAT THE MAYFIELD INFINITY SKULL CLAMP (B)(6) WAS POSITIONED IN LOCKING FOR "POSTERIOR CERVICAL FUSION" PROCEDURE WHEN IT RELEASED CAUSING INJURY TO THE PATIENT. BLEEDING WAS OBSERVED FROM THE LACERATION AND THE SURGEON PLACED STAPLES ON THE LACERATION. THE MAYFIELD PIN WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER MAYFIELD PIN HEADREST. THERE WAS ABOUT 20-30 MINUTES OF SURGICAL DELAY AS A RESULT OF PRODUCT PROBLEM.
Patient problems: Laceration(s)
MAUDE report 21945010 ↗InjuryJan 3, 2025Unstable; Unstable
A FACILITY REPORTED THAT THE MAYFIELD INFINITY SKULL CLAMP (A1114) MOVED AND THE PATIENT SLIPPED OUT OF THE PINS RESULTING IN AN UNSPECIFIED PATIENT INJURY. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Unspecified Tissue Injury
MAUDE report 21074577 ↗InjuryNov 27, 2024Device Slipped; Device Slipped
A FACILITY REPORTED THAT THE MAYFIELD INFINITY SKULL CLAMP (A1114) SLIPPED RESULTING IN PATIENT LACERATION. THE ROCKER AND SINGLE PIN WERE LOCKED, AND 60 PSI WAS CONFIRMED. WHEN THE PATIENT MOVED, DRAPES WERE REMOVED, AND PSI WAS DOWN TO 40. LACERATION WAS STAPLED TO CLOSE. THE PATIENT WAS RE-POSITIONED IN A NEW 3 PIN SKULL CLAMP, AND NO ISSUES WERE NOTED WITH THE SECOND 3 PIN SKULL CLAMP. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Laceration(s)
MAUDE report 20803066 ↗InjuryNov 8, 2024Device Slipped; Device Slipped
InjuryNov 8, 2024Unstable; Unstable
MalfunctionAug 21, 2024Unstable; Mechanical Jam; Unstable; Mechanical Jam
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2024-00097: A FACILITY REPORTED THAT THE MAYFIELD INFINITY SKULL CLAMP (A1114) WOULD NOT RELEASE AND THE PINS SHIFTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20018141 ↗MalfunctionAug 20, 2024Unstable; Mechanical Jam; Unstable; Mechanical Jam
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2024-00096: A FACILITY REPORTED THAT THE MAYFIELD INFINITY SKULL CLAMP (A1114) WOULD NOT RELEASE AND THE PINS SHIFTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20005056 ↗InjuryJun 24, 2024Device Slipped; Device Slipped
A FACILITY REPORTED THAT THE MAYFIELD INFINITY SKULL CLAMP (A1114) SLIPPED AFTER THE CLAMP WAS PINNED AND LOCKED TO SECURE PATIENT'S HEAD AND NECK FOR POSTERIOR CERVICAL FUSION SURGERY. THE FACILITY'S TEAM REMOVED THE CLAMP AND THE SURGEON RE-PINNED AND LOCKED THE CLAMP ONTO THE PATIENT'S HEAD AND THE CLAMP SLIPPED A SECOND TIME. THE PATIENT HAD 2 SCALP LACERATIONS FROM THE SLIPPAGE THAT WERE CLOSED WITH STAPLES. THERE WAS NO DELAY IN SURGERY.
Patient problems: Laceration(s)
MAUDE report 19601467 ↗MalfunctionMay 9, 2024Mechanical Jam; Mechanical Jam
A FACILITY REPORTED THAT THE MAYFIELD INFINITY SKULL CLAMP (A1114) WAS STUCK AND THE PLUNGER WOULD NOT RELEASE WHEN RELEASING FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19281057 ↗MalfunctionApr 12, 2024Use of Device Problem; Use of Device Problem
A FACILITY REPORTED THAT WHILE THE PATIENT WAS BEING POSITIONED IN THE MAYFIELD INFINITY SKULL CLAMP (A1114), TOO MUCH POUNDS OF PRESSURE WAS APPLIED TO THE PATIENT. NO INFORMATION ON PATIENT INJURY OR SURGICAL DELAY WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19096269 ↗InjuryMar 28, 2024Device Slipped; Device Slipped
A FACILITY REPORTED THAT DURING CRANIAL TUMOR RESECTION, THE PATIENT SLIPPED IN THE MAYFIELD INFINITY SKULL CLAMP (A1114), RESULTING IN A LACERATION. THE LACERATION WAS STAPLED AND SURGERY WAS DELAYED BY 15-20 MINUTES.
Patient problems: Laceration(s)
MAUDE report 18996880 ↗InjuryMar 8, 2024Device Slipped; Device Slipped
N/A.
Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 18871648 ↗MalfunctionMar 1, 2024Device Slipped; Device Slipped
A FACILITY REPORTED THAT THE PATIENT'S HEAD SLIPPED OUT OF THE MAYFIELD INFINITY SKULL CLAMP (A1114). THERE WAS NO PATIENT INJURY AND NO KNOWN SURGICAL DELAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18819554 ↗InjuryMar 1, 2024Device Slipped; Device Slipped
A FACILITY REPORTED THAT DURING PATIENT INITIAL POSITIONING FOR A "POSTERIOR CERVICAL" CASE SLIPPAGE OCCURRED WHILE PATIENT WAS PRONE. THE PATIENT HAD TO BE FLIPPED INTO SUPINE POSITION AND SCALP LACERATION WAS REPAIRED WITH SUTURES. PATIENT WAS ABLE TO BE RE-PINNED AND SURGERY WAS COMPLETED. NO INFORMATION ON SURGICAL DELAY WAS PROVIDED.
Patient problems: Laceration(s)
MAUDE report 18819520 ↗MalfunctionNov 16, 2023Mechanical Jam; Mechanical Jam
REFER TO MFG REPORT 3004608878-2023-00205: A FACILITY REPORTED THAT WHEN THEY ATTEMPTED TO USE THIS MAYFIELD INFINITY SKULL CLAMP (A1114) FOR A THIRD TIME, IT COULD NOT BE USED IN THE OPERATING ROOM (PRESENCE OF INTEGRA REP IN THE ROOM) DUE TO A MALFUNCTION: DIFFICULT TO CLOSE THE ARM AND IMPOSSIBLE TO TIGHTEN CORRECTLY. THE OPERATION ENDED WITH ANOTHER MAYFIELD THEY HAD IN STOCK AND A DELAY OF 90 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18152930 ↗MalfunctionAug 4, 2023Mechanical Problem; Mechanical Problem
MalfunctionApr 21, 2023Device Slipped; Unintended Movement; Device Slipped; Unintended Movement
THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2023-00068, 3004608878-2023-00069. A FACILITY REPORTED THAT THE PATIENT SLIPPED OUT OF THE MAYFIELD INFINITY SKULL CLAMP (A1114) DURING A CRANIOTOMY PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT DID NOT "SLIP OUT OF THE MAYFIELD" AS RECORDED, BUT THAT THE MAYFIELD MOVED WHILE THE SURGEON WAS PREPARING PATIENT FOR SURGERY. NO PATIENT INJURY HAS BEEN REPORTED; HOWEVER, THERE WAS A DELAY OF EXTRA 10 MINUTES FOR RE-REGISTERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16789627 ↗MalfunctionDec 28, 2022Device Slipped; Device Slipped
A FACILITY REPORTED THAT DURING A ROBOTIC-ASSISTED STEREO-TACTIC NEUROSURGICAL PROCEDURE, WHEN DRILLING THE DRILL HOLE, THE MAYFIELD INFINITY SKULL CLAMP (A114) DID NOT HOLD ITS POSITION. SLIPPAGE OF THE PATIENT'S HEAD OCCURRED DUE TO THE TWO-PRONGED ARM CLAMP NUT NOT HOLDING PROPERLY. THE PROCEDURE TO RECORD THE PATIENT'S CRANIAL VOLUME HAD TO BE REPEATED, EXTENDING THE PROCEDURE TIME BY MORE THAN 2 HOURS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16065263 ↗InjurySep 23, 2022Device Slipped; Device Slipped
INITIALLY, A FACILITY REPORTED TO OUR SERVICE & REPAIR TEAM THAT THE LOCKING MECHANISM ON THE MAYFIELD INFINITY SKULL CLAMP (A114) FOR SECURING THE HEAD PIN WAS NOT HOLDING. THE FACILITY DID NOT REPORT IF THERE WAS PATIENT INVOLVEMENT, INJURY, OR SURGICAL DELAY RELATIVE TO THIS FAILURE. SUBSEQUENTLY MEDWATCH UF/ IMPORTER REPORT # (B)(4) WAS RECEIVED ON 21SEP2022 WITH THE FOLLOWING INFORMATION: "MID TEEN¿S TEENAGE MALE DIAGNOSED WITH A BRAIN MASS. PLANS WERE MADE FOR ELECTIVE RESECTION AFTER A DISCUSSION OF RISKS AND BENEFITS WAS HELD WITH HIS FAMILY WHO AGREED TO PROCEED. SURGERY STARTED AND APPROX. 2HRS IN THE PT'S HEAD MOVED, PT CHECKED. PT'S HEAD WAS FOUND TO HAVE PARTIALLY SLIPPED OUT OF THE MAYFIELD HEAD HOLDER WITH LEFT SIDE OF FACE PRESSED AGAINST METAL MAYFIELD HEAD HOLDER. HEAD HOLDER WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A HORSESHOE PILLOW MAYFIELD ATTACHMENT. METAL MAYFIELD HEAD HOLDER WAS TESTED FOR MALFUNCTION BY NEUROSURGERY SPECIALIST TECH AND FOUND TO BE INTACT WITHOUT ISSUE. SURGEONS CONTINUED SURGERY AS PATIENT SEEMED UNHARMED BY THE EVENT AT THE TIME. END OF CASE THE PINS, WHICH WERE LEFT IN, WERE REMOVED. UPON REMOVAL, IT WAS FOUND THAT THE PIN ON THE LEFT
Patient problems: Laceration(s)
MAUDE report 15471694 ↗InjuryAug 25, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
A FACILITY REPORTED THAT A PATIENT LACERATION OCCURRED DURING USE OF THE MAYFIELD INFINITY SKULL CLAMP A1114 FOR AN UNSPECIFIED PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Laceration(s)
MAUDE report 15293893 ↗MalfunctionJun 29, 2022Mechanics Altered; Mechanics Altered
A FACILITY REPORTED THAT THE MAYFIELD SKULL CLAMP (A1114) OPENED ITSELF DURING "OPENING OF THE SKULL BONE VIA PERFORATOR" SURGERY. THE SKULL CLAMP WAS POSITIONED CORRECTLY AND WAS CHECKED BY STRETCHING ON BOTH SIDES OF THE CLAMP, BUT WHEN DRILLING THE BURR HOLES THE SURGEON REMARKED A "CLICK" OR A "POP" AND GOT THE FEELING THAT SOMETHING WAS LOOSENING. A CHECK BY THE NON-STERILE NURSE LED TO THE RESULT THAT THE SCALE OF THE PRESSURE KNOB WAS ON ZERO AND THE CLAMP WAS WITHOUT PRESSURE. THEN THEY CLOSED THE CLAMP AGAIN, AND SURGERY CONTINUED WITH THE SAME SKULL CLAMP. THE EVENT LED TO INCREASE SURGERY TIME FOR 15 MINUTES WITHOUT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14861339 ↗InjuryMar 10, 2022Unintended Movement; Unintended Movement
A FACILITY REPORTED THAT MAYFIELD INFINITY SKULL CLAMP (A1114) WAS USED FOR A CRANIOTOMY PROCEDURE, AND THE PATIENT WAS PINNED IN ROUTINE FASHION AND STABILITY WAS VERIFIED BY BOTH ATTENDING SURGEONS. NO WIGGLE WAS IDENTIFIED PRIOR TO PREPPING AND DRAPING. MIDWAY THROUGH THE CASE, THE PATIENT'S HEAD SLIPPED AND CLEARLY SUNK LOWER TO THE GROUND. UPON IMMEDIATE EXAMINATION, IT WAS NOTED THAT THE DOUBLE PIN SITE HAD MOVED, LACERATING THE GALEA THROUGH THE CRANIUM. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT REQUIRED REPOSITIONING ONCE THE CLAMP WAS REMOVED TO PERFORM A MULTILAYER CLOSURE OF THE APPROXIMATELY 2-INCH-LONG LACERATION OF THE SCALP. THE PATIENT WAS DISCHARGED IN NORMAL FASHION POST-OPERATIVELY IN ACCORDANCE WITH HER DIAGNOSIS, THIS INCIDENT DID NOT PROLONG HER IN-PATIENT STATUS. NO SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: Laceration(s)
MAUDE report 13720242 ↗
Other HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) devices
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- 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.