MAYFIELD® A3101Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® 2 Base Unit, Standard · Class 1
Quick summary
This Integra Mayfield A3101 skull clamp base unit holds a patient's head steady during brain and spine surgery. Most of the 33 reports describe the frame slipping or shifting even when the pins appeared locked, plus looseness and mechanical problems that required tightening or swapping mid-case. Eleven reports mention injuries such as scalp cuts needing stitches and pressure on the eye. No deaths were reported, no recalls name this device, and no reports were filed in the past 12 months, compared with 8 in the prior 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
- 34
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10381780268161), received between Mar 10, 2021 and Sep 28, 2026 — classified as 11 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (13 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 Slipped13
- Mechanical Problem5
- Unintended Movement4
- Mechanics Altered3
- Unstable3
- Adverse Event Without Identified Device or Use Problem2
- Physical Resistance/Sticking2
- Device Handling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Laceration(s)6
- Insufficient Information4
- Bacterial Infection1
- Blister1
- Bone Fracture(s)1
- Eye Injury1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryJul 21, 2025Unstable; Unstable
A FACILITY REPORTED THAT A PATIENT SUFFERED HARM DURING SHIFT IN POSITIONING, AND THAT THE MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD (A3101) NEEDS TO BE TIGHTENED. THE PATIENT UNDERWENT "ANTERIOR DENS SCREW AND C3-C6 POSTERIOR SPINAL FUSION PROCEDURE", AND WHEN THE MAYFIELD MALFUNCTIONED, IT BECAME MISALIGNED WITH THE PATIENT'S FACE WHICH LED TO PRESSURE POINTS ON THE PATIENT'S EYEBALL. NO SURGICAL DELAY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Eye Injury
MAUDE report 22554753 ↗InjuryMar 13, 2025Device Slipped; Device Slipped
THIS REPORT IS 2 OF 3 AND IS LINKED TO MFG REPORT NUMBERS 3004608878-2025-00046 AND 3004608878-2025-00048: A FACILITY REPORTED THAT DURING A CHIARI REPAIR CASE, THE MAYFIELD COMPOSITE SERIES BASE UNIT (A3101) SLIPPED ON THE PATIENT'S SKULL DESPITE ALL THREE PINS APPEARING FULLY LOCKED IN PLACE. LACERATIONS OCCURRED ON BOTH SIDES OF PATIENT'S SKULL AND REQUIRED STAPLING. THE MAYFIELD SET UP WAS REMOVED AND REPLACED WITH AN ALTERNATIVE KIT, AND THE SURGEON PROCEEDED WITH THE OPERATION. THERE WAS SURGICAL DELAY OF APPROXIMATELY 20 MINUTES.
Patient problems: Laceration(s)
MAUDE report 21598665 ↗InjuryFeb 21, 2025Device Handling Problem; Device Handling Problem
THIS REPORT IS 7 OF 7 FOR MAYFIELD SKULL CLAMP A3101) AND IS LINKED TO MFG REPORT NUMBERS: 1121308-2025-00001, 3006697299-2025-00004, 3006697299-2025-00005, 3006697299-2025-00006, 3006697299-2025-00009, 3004608878-2025-00010. A FACILITY REPORTED THAT DURING CRANIOTOMY CASES THEY HAVE BEEN SEEING POST-OPERATIVE INFECTIONS ¿CUTIBACTERIUM ACNES BACTERIA¿ ALL INVOLVING THE SAME DOCTOR AFTER USING CUSA DEVICES AND DURAGEN. THE INTEGRA ACCOUNT MANAGER (IAM) ASKED IF THEY HAD BEEN LOOKING AT THEIR DEVICES SINCE HE OBSERVED THAT THEY WERE NOT CLEANING THE MAYFIELD EQUIPMENT PROPERLY. AS A RESULT, THE IAM PROVIDED BOTH THE MAYFIELD AND CUSA CLEANING INSTRUCTIONS TO THE FACILITY. THE CUSTOMER IS NOT SURE WHICH DEVICE MAY BE CAUSING THE INFECTIONS BUT ARE ALSO USING OTHER MANUFACTURER¿S PRODUCTS AND HAVE CONTACTED THEM AS WELL. DURING PREOPERATIVE SUPPORT FOR ANOTHER CASE, THE IAM DID OBSERVE THAT THE OPENED CUSA TRAY ON THE STERILE FIELD HAD A PREVIOUSLY USED TIP STILL ATTACHED TO THE CUSA 23K HANDPIECE, AND THERE WAS A PREVIOUSLY USED DISPOSABLE WRENCH ALSO IN THE TRAY. THE SURGICAL TEAM HAD TO BREAK DOWN THE STERILE FIELD AND SENT ALL THE ITEMS BACK TO SPD. THE FACILITY IS PRIMARILY CONCER
Patient problems: Bacterial Infection
MAUDE report 21433744 ↗MalfunctionJan 8, 2025Unstable; Unstable
A FACILITY REPORTED THAT THERE IS POSSIBLY AN ISSUE WITH THE TEETH OF THE MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD (A3101) AND THEY HAD TO CHANGE OUT THE DEVICE DUE TO HEAD MOVEMENT THAT OCCURRED DURING THE CASE. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21105396 ↗MalfunctionDec 17, 2024Device Slipped; Device Slipped
MalfunctionDec 12, 2024Device Slipped; Device Slipped
A FACILITY REPORTED THAT THERE WAS A SLIP RELATED TO TRANSITIONAL ARM CONNECTION ON THE MAYFIELD COMPOSITE SERIES BASE UNIT (A3101). NO INFORMATION ON PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20919967 ↗MalfunctionNov 8, 2024Device Slipped; Device Slipped
MalfunctionNov 8, 2024Device Slipped; Device Slipped
A FACILITY SUSPECTED THAT THE STARBURST ON THE MAYFIELD COMPOSITE SERIES BASE UNIT (A3101) THAT CONNECTS BETWEEN THE BASE UNIT AND SWIVEL ADAPTER FAILED WHILE THE PATIENT'S HEAD WAS SECURED CAUSING A SLIP. THE UNIT WAS USED FOR CRANIAL STABILIZATION (CERVICAL LAMINECTOMY + FORAMINOTOMY). PATIENT INJURY, SURGICAL DELAY AND PATIENT OUTCOME IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20644903 ↗MalfunctionOct 24, 2024Device Slipped; Device Slipped
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2024-00122: A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SERIES BASE UNIT (A3101) WAS SLIPPING DURING USE AND THINKS THE SWIVEL LOCK IS NOT LOCKING. NO INFORMATION ON PATIENT INJURY OR SURGICAL DELAY HAS BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20524311 ↗InjurySep 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2024-00110: A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SERIES BASE UNIT (A3101) IS TOO STIFF WHEN LOCKING (ALWAYS IS WITH A NEW UNIT). WHEN THEY TRIED TO CLOSE IT, THE USER'S HAND GOT CAUGHT AND PINCHED IN THE LOCKING MECHANISM RESULTING IN A FRACTURED FINGER TIP.
Patient problems: Bone Fracture(s)
MAUDE report 20204100 ↗InjurySep 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2024-00111: A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SERIES BASE UNIT (A3101) IS TOO STIFF WHEN LOCKING (ALWAYS IS WITH A NEW UNIT). WHEN THEY TRIED TO CLOSE IT, THE USER'S HAND GOT CAUGHT AND PINCHED IN THE LOCKING MECHANISM RESULTING IN A BLOOD BLISTER.
Patient problems: Blister
MAUDE report 20202969 ↗MalfunctionApr 11, 2024Device Slipped; Device Slipped
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2024-00048: A FACILITY REPORTED THAT DURING USE OF THE MAYFIELD COMPOSITE SERIES BASE UNIT (A3101) FOR A NUERO CASE, SLIPPAGE OCCURRED. NO INFORMATION ON PATIENT INJURY OR SURGICAL DELAY HAS BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19090534 ↗InjuryNov 22, 2023Device Slipped; Device Slipped
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2023-00211. A FACILITY REPORTED THAT DURING REVISION POSTERIOR FOSSA DECOMPRESSION PROCEDURE, THE MAYFIELD MODIFIED SKULL CLAMP (A1059) WHICH WAS USED FOR CRANIAL STABILIZATION SLIPPED ON THE PATIENT'S RIGHT SIDE WHERE THE 2 PINS WERE POSITIONED. THIS LED TO A FULL-THICKNESS LACERATION OF APPROXIMATELY 5CM NEXT TO THE VP SHUNT, REQUIRING CLEANING AND SUTURING. AS A RESULT, THE SURGERY WAS CANCELLED. NO FURTHER DETAILS REGARDING CRANIOFACIAL ISSUES HAS BEEN PROVIDED. FURTHER INFORMATION PROVIDED INDICATES THAT THE HOSPITAL DOES ITS OWN MAYFIELD INSPECTION ONCE PER YEAR, AND INTEGRA'S ACCOUNT MANAGER HAS ADVISED HE HAS DISCUSSED RETRAINING. HOWEVER, THE DEVICES ARE BEING RETURNED TO INTEGRA SERVICE TO BE EVALUATED.
Patient problems: Laceration(s)
MAUDE report 18196423 ↗MalfunctionOct 5, 2023Unintended Movement; Unintended Movement
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2023-00174:A FACILITY REPORTED THAT A SURGEON OBSERVED AN EXCESS MOVEMENT ON A MAYFIELD COMPOSITE SERIES BASE UNIT (A3101) DURING AN UNSPECIFIED SURGICAL PROCEDURE. NO INFORMATION HAS BEEN PROVIDED ON PATIENT CONSEQUENCE OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17881320 ↗MalfunctionJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD (A3101) WAS INVOLVED IN A SLIPPAGE INCIDENT AND THEY WERE UNSURE IF PATIENT INJURY OCCURRED. ADDITIONAL INFORMATION WAS LATER RECEIVED AS FOLLOWS: "AFTER FURTHER INVESTIGATION AND DISCUSSION WITH THE ACCOUNT, THE ISSUE APPEARS TO LIE WITH THE DORO SKULL CLAMP THAT WAS USED. ALL OF THE CONNECTIONS BETWEEN THE INTEGRA PARTS REMAINED SOLID THE ENTIRE TIME BUT THE HEAD SLIPPED OUT OF THE PINS ON THE DORO SKULL CLAMP... THE INTEGRA PARTS USED DURING THE CASE WERE NOT THE ISSUE." INTEGRA HAS FORWARDED DETAILS OF THE COMPLAINT EVENT TO "BLACK FOREST MEDICAL GROUP" WHO IS THE MANUFACTURER OF THE "DORO SKULL CLAMP."
Patient problems: Insufficient Information
MAUDE report 17100910 ↗MalfunctionFeb 16, 2023Device Slipped; Device Slipped
MalfunctionFeb 9, 2023Mechanical Problem; Mechanical Problem
A FACILITY REPORTED THAT THE ARM ON THE MAYFIELD COMPOSITE SERIES BASE UNIT A3101 WAS NOT SECURED AND CAME UNBOLTED DURING AN UNSPECIFIED PROCEDURE. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16337766 ↗InjuryDec 22, 2022Device Slipped; Device Slipped
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3004608878-2022-00276. A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SERIES BASE UNIT (A3101) WAS BEING USED FOR CRANIAL STABILIZATION AND SLIPPED WHILE PATIENT WAS BEING TURNED TO PRONE POSITION PRIOR TO COMMENCEMENT OF THE CASE. THE SLIPPAGE CAUSED SIGNIFICANT LACERATIONS TO THE PATIENT'S HEAD (6-7 CM) WHICH REQUIRED SUTURES TO CLOSE. THERE WAS A DELAY OF 20 MINUTES DUE TO PRODUCT PROBLEM.
Patient problems: Laceration(s)
MAUDE report 16040273 ↗InjuryNov 18, 2022Device Slipped; Device Slipped
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT #: 3004608878-2022-00248. A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SKULL CLAMP (A3059) AND THE MAYFIELD BASE UNIT (A3101) WAS USED FOR CRANIAL STABILIZATION DURING A "SUBOCCIPITAL CRANIOTOMY FOR TUMOR." THE SURGEON WAS POSITIONING THE PATIENT IN PRONE INTO SKULL CLAMP AND PREPARING THE SURGICAL FIELD WHEN A CLICKING SOUND WAS HEARD BUT IT WAS NOT CLEAR WHERE THE SOUND WAS COMING FROM. THE SURGEON FELT THAT THE SCREW WAS NOT TENSIONING ADEQUATELY AND THAT IT SLIPPED DURING PROCEDURE. THIS RESULTED IN A 4CM LACERATION FROM THE SKULL PIN TO THE REAR OF THE PATIENT'S SKULL WHICH WAS CLOSED WITH SUTURES. AFTER THE CASE, THE SURGEON COMMENTED THAT THE SCREW HAD AGAIN COME LOOSE IN ITS TENSIONING. SURGERY WAS DELAYED FOR 15 MINUTES.
Patient problems: Laceration(s)
MAUDE report 15828857 ↗InjuryOct 7, 2022Device Slipped; Device Slipped
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2022-00206. A FACILITY REPORTED THAT MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD (A3101) WAS USED FOR A POSTERIOR CERVICAL FUSION, AND PATIENT SLIPPAGE OCCURRED WHICH CAUSED LACERATION TO THE POSTERIOR LATERAL SCALP OF THE PATIENT. STAPLES WERE PLACED TO CLOSE THE LACERATION, AND DIFFERENT MAYFIELD DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS LESS THAN 30 MINUTES DELAY ON SURGERY. ADDITIONAL INFORMATION RECEIVED INDICATES THAT IT IS UNKNOWN IF THE DEVICES SLIPPED OR IF IT WAS DUE TO APPLICATION. BOTH DEVICES THAT WERE INVOLVED IN THE INCIDENT ARE BEING SENT BACK FOR EVALUATION AS A PRECAUTION DUE TO THE PATIENT INJURY.
Patient problems: Laceration(s)
MAUDE report 15562941 ↗MalfunctionSep 30, 2022Mechanics Altered; Mechanics Altered
A FACILITY REPORTED THAT THE MAYFIELD COMPOSITE SERIES BASE UNIT (A3101) WAS WOBBLING DURING A "CRANIOTOMY FOR LESION" PROCEDURE, THE "TEETH" OR STARBURSTS WAS NOT GRIPPING IN. THERE WAS A MINIMAL DELAY IN SURGERY TO STABILIZE THE UNIT. THE PATIENT HAD ALREADY BEEN PINNED IN THE CLAMP, SO THEY CONTINUED WITH THE CASE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15512894 ↗MalfunctionSep 30, 2022Mechanics Altered; Mechanics Altered
A FACILITY REPORTED THAT DURING "EMERGENCY CLIPPING OF ANEURYSM", THE POOL - MAYFIELD 2 SERIES BASE UNIT STANDARD (A3101P) WAS WOBBLING AND THE TEETH OR STARBURSTS WAS NOT GRIPPING IN. THE UNIT WAS REPLACED PRIOR TO PREP AND DRAPING FOR THE CLIPPING OF THE ANEURYSM. THERE WAS A 15 TO 20 MINUTES SURGICAL DELAY; HOWEVER, NO PATIENT INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15512634 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPORTED THAT PATIENT SLIPPAGE AND INJURY OCCURRED DURING USE OF THE MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD (A3101). ADDITIONAL INFORMATION HAS BEEN REQUESTED TO DETERMINE THE NATURE OF THE INJURY AND PATIENT OUTCOME. NO SURGICAL DELAY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 15324769 ↗MalfunctionJun 22, 2022Mechanics Altered; Mechanics Altered
A FACILITY REPORTED THAT THE MAYFIELD BASE UNIT (A3101) WAS CONNECTED TO THE MAYFIELD SWIVEL ADAPTOR AT THE BEGINNING OF A PROCEDURE AND APPROXIMATELY 30 MINUTES AFTER THE START OF THE OPERATION, THE BLACK SCREW ON THE SWIVEL BECAME LOOSE AND COULD BE FIXED IN PLACE BY A COMPLETE TURN. ADDITIONAL INFORMATION RECEIVED INDICATES THAT INTRAOPERATIVELY, THE SURGEON NOTICED THAT THE PATIENT'S HEAD HAD SAGGED WITH THE MAYFIELD. THEY HAD TO REMOVE THE DRAPE AND REPOSITION THE PATIENT, WHICH ADDED ABOUT 45 MINUTES TO THE OPERATING ROOM TIME. THERE WAS NO PATIENT INJURY BECAUSE THE SURGEON REACTED QUICKLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14776839 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.