MAYFIELD® A2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10381780253655), received between Mar 8, 2021 and May 8, 2026 — classified as 4 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K932807); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Unstable

  A FACILITY REPORTED THAT THE MAYFIELD SKULL CLAMP (A2000) WAS REPORTED TO BE LOOSE WHEN FASTENED TO A PATIENT DURING SURGERY. THE DEVICE WAS IN CONTACT WITH THE PATIENT AT THE TIME OF THE EVENT. NO PATIENT INJURY WAS REPORTED. IT IS UNKNOWN WHETHER THE EVENT RESULTED IN AN INCREASE IN SURGICAL TIME. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER REPORTED COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126413 ↗
• InjuryFeb 13, 2026Device Slipped

  A FACILITY REPORTED THAT AFTER THE MAYFIELD 2000 SKULL CLAMP (A2000) WAS CLAMPED ONTO THE PATIENT, THERE WAS SLIPPAGE DURING PATIENT REPOSITIONING AND BEFORE SURGICAL INCISION. THIS SLIPPAGE CAUSED A SMALL TEAR IN THE SCALP THAT REQUIRED SUTURES. THERE WAS A DELAY OF 30 MINUTES IN SURGERY DUE TO PRODUCT PROBLEM.

  Patient problems: Laceration(s)

  MAUDE report 24334270 ↗
• MalfunctionNov 6, 2025Device Slipped; Device Slipped

  N/A.

  Patient problems: Laceration(s)

  MAUDE report 23490588 ↗
• InjuryFeb 26, 2025Device Slipped; Device Slipped

  A FACILITY REPORTED THAT THE MAYFIELD 2000 SKULL CLAMP (A2000) DID NOT HOLD (LOST PRESSURE WHEN CLAMPED), AND SLIPPED WHILE ON PATIENT'S HEAD CAUSING LACERATION. NO INFORMATION HAS BEEN PROVIDED ON SURGICAL DELAY.

  Patient problems: Laceration(s)

  MAUDE report 21472329 ↗
• MalfunctionOct 3, 2024Unstable; Unstable

  A FACILITY REPORTED THAT THE MAYFIELD 2000 SKULL CLAMP (A2000) RELEASED DURING PINNING. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363547 ↗
• InjuryMay 2, 2024Device Slipped; Device Slipped

  A FACILITY REPORTED THAT AN ISSUE RELATED TO THE INABILITY TO REMOVE OR LOOSEN THE TORQUE SCREW ON THE MAYFIELD 2000 SKULL CLAMP (A2000) OCCURRED. THIS ISSUE INITIATED A PIN SLIPPAGE CAUSING A 1.5 TO 2CM LACERATION WHICH WAS REPAIRED WITH ABSORBABLE SUTURE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE AND THE PATIENT DID WELL WITH NO INCREASE OF HOSPITAL STAY.

  Patient problems: Laceration(s)

  MAUDE report 19235102 ↗
• MalfunctionFeb 8, 2024Unintended Movement; Unintended Movement

  A FACILITY REPORTED THAT THE MAYFIELD 2000 SKULL CLAMP (A2000) WAS LOOSE AND SEEMED LIKE IT HAD TOO MUCH PLAY. NO INFORMATION HAS BEEN PROVIDED ON PATIENT INVOLVEMENT, INJURY, OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18673250 ↗
• MalfunctionApr 13, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  A FACILITY REPORTED THAT THEY HAD A DIFFICULT TIME TURNING THE KNOB ON THE MAYFIELD SKULL CLAMP (A2000) TO INCREASE PRESSURE. THE DEVICE BECAME STUCK AT THE END AND WOULD NOT UNLOCK, AND THEY HAD TO USE A WRENCH TO REMOVE IT FROM THE PATIENT'S HEAD. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738763 ↗
• MalfunctionMar 16, 2023Mechanical Problem; Mechanical Problem

  A FACILITY REPORTED THAT THE SURGEON STRUGGLED TO RELEASE THE MAYFIELD SKULL CLAMP (A2000) ONCE IT WAS SEARED TO THE PATIENT'S SKULL. THERE WAS NO PATIENT INJURY AND DELAY IN SURGERY IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16557925 ↗
• MalfunctionMar 10, 2023Mechanical Problem; Mechanical Problem

  A FACILITY REPORTED THAT THE MAYFIELD 2000 SKULL CLAMP (A2000) WAS NOT LOCKING CORRECTLY. NO INFORMATION HAS BEEN PROVIDED ON PATIENT INVOLVEMENT, INJURY, OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527037 ↗
• MalfunctionFeb 9, 2023Mechanics Altered; Mechanics Altered

  A FACILITY REPORTED THAT THE LOCKING MECHANISM ON THE MAYFIELD SKULL CLAMP (A2000) WAS LOOSE. THE UNIT WAS USED FOR A CRANIOTOMY CASE. THERE WAS NO PATIENT INJURY NOR DELAY IN SURGERY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16339186 ↗
• MalfunctionNov 18, 2022Unintended Movement; Unintended Movement

  A FACILITY REPORTED THAT THE MAYFIELD 2000 SKULL CLAMP (A2000) WAS ON A PATIENT AND THERE WAS A LITTLE MOVEMENT OF THE LOCKING MECHANISM. THERE WAS NO PATIENT INJURY NOTED AND NO DELAY IN SURGERY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827404 ↗
• MalfunctionOct 27, 2022Mechanics Altered; Mechanics Altered

  A FACILITY REPORTED THAT THE LOCKING MECHANISM ON MAYFIELD 2000 SKULL CLAMP (A2000) WAS FAULTY AND CAME LOOSE, DROPPING THE PATIENT'S HEAD. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686578 ↗
• InjuryOct 13, 2022Mechanics Altered; Mechanics Altered

  A FACILITY REPORTED THAT THE LOCKING MECHANISM ON THE MAYFIELD SKULL CLAMP (A2000) WAS FAULTY AND CAME LOOSE DURING AN UNSPECIFIED CASE, DROPPING THE PATIENT'S HEAD AND PATIENT SLIPPED. THERE WAS AN UNSPECIFIED PATIENT INJURY AND DELAY IN SURGERY IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15601517 ↗
• MalfunctionOct 7, 2022Mechanical Jam; Mechanical Jam

  A FACILITY REPORTED THAT DURING THE FINAL STAGE OF AN UNSPECIFIED SURGICAL PROCEDURE (DURING SKULL RELEASING), THE MECHANISM ON THE MAYFIELD 2000 SKULL CLAMP (A2000) WAS STICKING/JAMMING, AND EXTENSION BLOCKING BY PLUNGER MECHANISM AUTOMATIC CLICKING DID NOT WORK PROPERLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED IN THE NORMAL WAY, FINALLY RELEASING THE PATIENT'S SKULL FROM THE FAULTY MAYFIELD CLAMP. THERE WAS A 2-3 MINUTES DELAY WITHOUT PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15563232 ↗
• MalfunctionMay 7, 2022Device Slipped; Device Slipped

  THIS IS 2 OF 6 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00082, 3004608878-2022-00084, 3004608878-2022-00085, 3004608878-2022-00086, 3004608878-2022-00087. A FACILITY REPORTED THAT THEY WERE HAVING ISSUES WITH THEIR NEW MAYFIELD 2000 SKULL CLAMPS A2000 SLIPPING DURING SURGERY EVEN THOUGH THEY ARE LOCKED. ADDITIONALLY, THEY STATED THAT THERE IS A MECHANISM CUSTOMER DESCRIBE AS "WASHERS" THAT LOOSENS OVER TIME, AND THE LOCKING MECHANISM DOES NOT FUNCTION PROPERLY. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14319767 ↗
• MalfunctionMay 7, 2022Device Slipped; Device Slipped

  THIS IS 1 OF 6 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00083, 3004608878-2022-00084, 3004608878-2022-00085, 3004608878-2022-00086, 3004608878-2022-00087. A FACILITY REPORTED THAT THEY WERE HAVING ISSUES WITH THEIR NEW MAYFIELD 2000 SKULL CLAMPS (A2000) SLIPPING DURING SURGERY EVEN THOUGH THEY ARE LOCKED. ADDITIONALLY, THEY STATED THAT THERE IS A MECHANISM (CUSTOMER DESCRIBE AS "WASHERS") THAT LOOSENS OVER TIME, AND THE LOCKING MECHANISM DOES NOT FUNCTION PROPERLY. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14319236 ↗
• MalfunctionMay 7, 2022Device Slipped; Device Slipped

  THIS IS 6 OF 6 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00082, 3004608878-2022-00083, 3004608878-2022-00084, 3004608878-2022-00085, 3004608878-2022-00086. A FACILITY REPORTED THAT THEY WERE HAVING ISSUES WITH THEIR NEW MAYFIELD 2000 SKULL CLAMPS (A2000) SLIPPING DURING SURGERY EVEN THOUGH THEY ARE LOCKED. ADDITIONALLY, THEY STATED THAT THERE IS A MECHANISM (CUSTOMER DESCRIBE AS "WASHERS") THAT LOOSENS OVER TIME, AND THE LOCKING MECHANISM DOES NOT FUNCTION PROPERLY. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14319154 ↗
• MalfunctionMay 7, 2022Device Slipped; Device Slipped

  THIS IS 3 OF 6 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00082, 3004608878-2022-00083, 3004608878-2022-00085, 3004608878-2022-00086, 3004608878-2022-00087. A FACILITY REPORTED THAT THEY WERE HAVING ISSUES WITH THEIR NEW MAYFIELD 2000 SKULL CLAMPS (A2000) SLIPPING DURING SURGERY EVEN THOUGH THEY ARE LOCKED. ADDITIONALLY, THEY STATED THAT THERE IS A MECHANISM (CUSTOMER DESCRIBE AS "WASHERS") THAT LOOSENS OVER TIME, AND THE LOCKING MECHANISM DOES NOT FUNCTION PROPERLY. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14319151 ↗
• MalfunctionMay 7, 2022Device Slipped; Device Slipped

  THIS IS 4 OF 6 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00082, 3004608878-2022-00083, 3004608878-2022-00084, 3004608878-2022-00086, 3004608878-2022-00087. A FACILITY REPORTED THAT THEY WERE HAVING ISSUES WITH THEIR NEW MAYFIELD 2000 SKULL CLAMPS (A2000) SLIPPING DURING SURGERY EVEN THOUGH THEY ARE LOCKED. ADDITIONALLY, THEY STATED THAT THERE IS A MECHANISM (CUSTOMER DESCRIBE AS "WASHERS") THAT LOOSENS OVER TIME, AND THE LOCKING MECHANISM DOES NOT FUNCTION PROPERLY. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14319092 ↗
• MalfunctionMay 7, 2022Device Slipped; Device Slipped

  THIS IS 5 OF 6 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00082, 3004608878-2022-00083, 3004608878-2022-00084, 3004608878-2022-00085, 3004608878-2022-00087. A FACILITY REPORTED THAT THEY WERE HAVING ISSUES WITH THEIR NEW MAYFIELD 2000 SKULL CLAMPS (A2000) SLIPPING DURING SURGERY EVEN THOUGH THEY ARE LOCKED. ADDITIONALLY, THEY STATED THAT THERE IS A MECHANISM (CUSTOMER DESCRIBE AS "WASHERS") THAT LOOSENS OVER TIME, AND THE LOCKING MECHANISM DOES NOT FUNCTION PROPERLY. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14318931 ↗
• MalfunctionMay 4, 2022Mechanics Altered; Mechanics Altered

  A FACILITY REPORTED THAT THE ROCKER ARM ON MAYFIELD 2000 SKULL CLAMP (A2000) WAS LOOSE EVEN AFTER LOCKING THE KNOB. THERE WAS A DELAY FOR 10 MINUTES WITH NO PATIENT INJURY. THE DEVICE WAS CHANGED AND SURGERY WAS PERFORMED WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283072 ↗
• MalfunctionApr 28, 2022Unintended Movement; Unintended Movement

  A FACILITY REPORTED THAT THE "C" CLAMP ON THE MAYFIELD 2000 SKULL CLAMP (A2000) COULD NOT HOLD THE FULLY FIXED POSITION AND HAS A LITTLE MOVEMENT EVEN WHEN THE LATCH IS IN THE CLOSED POSITION. THEY BELIEVE THIS IS A CRITICAL FAULT DURING SURGERY. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14239720 ↗
• MalfunctionMar 10, 2022Unintended Movement; Unintended Movement

  A FACILITY REPORTED THAT THE MAYFIELD 2000 SKULL CLAMP (A2000) HAS TOO MUCH PLAY/GIVE WHEN TIGHTENED DOWN ON FIXATION PINS AND WHEN APPLIED TO THE PATIENT'S SKULL. THE DEVICE SEEMED TO MOVE OR BE LOOSE WHEN IT SHOULD BE TIGHT. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720658 ↗
• MalfunctionDec 30, 2021Unintended Movement; Unintended Movement

  A FACILITY REPORTED THAT THE MAYFIELD SKULL CLAMP (A2000) WAS LOOSE AND NEEDED TO BE REPAIRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED. UPON EVALUATION, IT SHOWED THAT THE DEVICE HAD MOVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120176 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932807. One submission often covers many models, so check the product and lot details in each record.

• Z-0548-2021 · Nov 11, 2020 · Terminated
  Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000