MAYFIELD® A1108Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10381780253518), received between Mar 11, 2021 and Mar 31, 2026 — classified as 8 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (12 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026

  MAYFIELD CLAMP DID NOT TORQUE PROPERLY DURING APPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741273 ↗
• MalfunctionJan 8, 2026Device Slipped

  A FACILITY REPORTED THAT THE MAYFIELD TRIAD SKULL CLAMP (A1108) IS SLIPPING, AND NEEDS REPAIR. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY OR PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24012145 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT DURING A CASE THEY ENCOUNTERED A PROBLEM WITH THE MAYFIELD TRIAD SKULL CLAMP (A1108) WHICH RESULTED IN A SMALL FRACTURE TO THE PATIENT'S SKULL. THE EXACT PROBLEM ENCOUNTERED WITH THE DEVICE HAS NOT BEEN REPORTED. THE CASE PROCEEDED WITH A NON MAYFIELD SKULL POSITIONING DEVICE. THE FACILITY ALSO NOTED THAT THE SURGEON IS AN EXTREMELY EXPERIENCED MAYFIELD USER WITH OVER 20 YEARS OF PRACTICE AND IS EXTREMELY CAUTIOUS WHEN APPLYING THE SKULL CLAMP. NO SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: Skull Fracture

  MAUDE report 23383837 ↗
• InjuryJun 10, 2025Device Slipped; Device Slipped

  A FACILITY REPORTED THAT THE PATIENT'S HEAD WAS POSITIONED IN THE MAYFIELD TRIAD SKULL CLAMP (A1108) AND PINS, AND DURING THE CASE, THE PATIENT'S HEAD SLIPPED CAUSING A LACERATION REQUIRING SUTURING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Laceration(s)

  MAUDE report 22180715 ↗
• MalfunctionApr 24, 2025Unstable; Unstable

  THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS 3004608878-2025-00079 AND 3004608878-2025-00081: A FACILITY REPORTED THAT ONCE FIXED, THE MAYFIELD TRIAD SKULL CLAMP (A1108) WAS NOT STABLE. THE PROBLEM WAS FOUND ON THE PATIENT UNDER ANESTHESIA, BEFORE THE SURGERY. SINCE THE PATIENT COULD NOT GIVE UP THIS SURGERY, WE MINIMIZED THE MOVEMENT OF THE HEADBOARD AS MUCH AS POSSIBLE, TAKING INTO ACCOUNT ITS IMPERFECT STABILITY FOR THE ENTIRE DURATION OF THE SURGERY. THERE WAS NO INCREASED SURGERY TIME OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901868 ↗
• MalfunctionFeb 6, 2025Unstable; Unstable

  A FACILITY REPORTED THAT THE MAYFIELD TRIAD SKULL CLAMP (A1108) DOES NOT HOLD POSITION. THE ISSUE WAS DETECTED DURING THE INTERVENTION, BUT THE PROCEDURE CONCLUDED REGULARLY, AND THE SURGERY WAS PERFORMED WITH THE SAME DEVICE, SINCE THEY NOTICED THE DEFECT ALMOST AT THE END OF THE SURGERY. THERE WAS NO INCREASED SURGERY TIME AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323208 ↗
• MalfunctionDec 18, 2024Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20973142 ↗
• MalfunctionOct 15, 2024Unstable; Unstable

  A FACILITY REPORTED THAT THE PATIENT WAS SECURED IN PINS FOR POSTERIOR CERVICAL LAMINECTOMY SURGERY IN PRONE POSITION, AND FOR SOME UNKNOWN REASON THE MAYFIELD TRIAD SKULL CLAMP (A1108) OPENED (CAME LOOSE), AND THE PATIENT'S HEAD BECAME FREE. A STAFF MEMBER WAS THERE AND ABLE TO SUPPORT THE HEAD UNTIL THE SURGEON WAS CALLED BACK. THE STAFF MEMBER HELD THE HEAD WHILE THE PATIENT WAS CHECKED FOR LACERATIONS AND THEN RE-PINNED. APPROXIMATE TIME OF DELAY IS UNKNOWN. THE SURGERY WAS COMPLETED WITH NO FURTHER ISSUES, AND NO PATIENT INJURY WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452332 ↗
• InjuryJul 17, 2024Unstable; Unstable

  A FACILITY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE PATIENT'S HEAD MOVED IN THE MAYFIELD TRIAD SKULL CLAMP (A1108), AND IT WAS OBSERVED THAT THE PATIENT'S FACE WAS PRESSED AGAINST CROSSBAR AND THERE WAS A LACERATION ON THE SIDE OF THE PATIENT'S HEAD. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED AS FOLLOWS: 1. PLEASE PROVIDE PATIENT INFORMATION: A. DATE OF BIRTH: >> UNWILLING TO SHARE B. GENDER: >> UNWILLING TO SHARE C. ETHNICITY (HISPANIC/LATINO, NOT HISPANIC/LATINO): >> UNWILLING TO SHARE D. RACE (ASIAN, AMERICAN INDIAN OR ALASKAN NATIVE, BLACK OR AFRICAN AMERICAN, WHITE, NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER) >> UNWILLING TO SHARE. 2. WHAT TYPE OF PROCEDURE WAS PERFORMED? >> POSTERIOR CERVICAL. 3. PLEASE PROVIDE THE SIZE AND LOCATION OF THE LACERATION. >> LEFT SIDE, BEHIND EAR, APPROXIMATELY 4 INCHES. 4. WAS THERE A DELAY IN SURGERY DUE TO PRODUCT PROBLEM? IF YES, HOW LONG? >> CAUSED AT LEAST 1HR DELAY OR MORE DURING THE CASE. 5. WAS THERE A REVISION/MEDICAL INTERVENTION REQUIRED? >> STITCHES AND WOUND CARE POST-OP. 6. HOW WAS THE PROCEDURE COMPLETED? >> REPOSITIONED TWO SEPARATE TIMES AND CONTINUED WITH THE PROCEDURE. 7. PATIENT OUTCOME/CURRENT CONDITION? >> UN

  Patient problems: Laceration(s)

  MAUDE report 19767081 ↗
• InjuryJul 17, 2024Device Slipped; Device Slipped

  N/A.

  Patient problems: Laceration(s)

  MAUDE report 19760657 ↗
• MalfunctionMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279044 ↗
• MalfunctionJan 5, 2024Device Slipped; Device Slipped

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2023-00249: A FACILITY REPORTED THAT THE MAYFIELD TRIAD SKULL CLAMP (A1108) SLIPPED ON A PATIENT DURING AN UNSPECIFIED CASE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING "TO MY KNOWLEDGE THIS HAD NO IMPACT ON THE SURGERY OR THE PATIENT. IT WAS BROUGHT TO THE OFFICE WITHOUT MUCH INFORMATION ON THE PROBLEM." NO INFORMATION HAS BEEN PROVIDED ON SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461018 ↗
• MalfunctionNov 9, 2023Device Slipped; Device Slipped

  A FACILITY REPORTED THAT THE MAYFIELD TRIAD SKULL CLAMP (A1108) SLIPPED, AND THAT THE PATIENT'S SKULL SHIFTED SLIGHTLY WHEN INSERTING A SCREW; HOWEVER, THE PATIENT WAS NOT INJURED. THE NURSES REPORTED THAT THE SKULL CLAMP REMAINED LOCKED. THEY WERE UNSURE IF THE SLIPPAGE CAME FROM 3RD PARTY BASE UNIT OR THE SKULL CLAMP. UPON INSPECTION, THE SKULL CLAMP APPEARED TO BE IN GREAT SHAPE WITH A LITTLE STARBURST WEAR. HOSPITAL HAS REQUESTED SERVICE FOR SAFETY PRECAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108108 ↗
• InjuryNov 2, 2023Unstable; Unstable

  N/A.

  Patient problems: Laceration(s)

  MAUDE report 18062401 ↗
• MalfunctionOct 19, 2023Mechanics Altered; Mechanics Altered

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17969971 ↗
• MalfunctionOct 5, 2023Device Slipped; Device Slipped

  A FACILITY REPORTED THAT THE PATIENT'S HEAD SLIPPED OUT OF THE PINS OF THE MAYFIELD TRIAD SKULL CLAMP (A1108) DURING AN UNSPECIFIED PROCEDURE. NO INFORMATION HAS BEEN PROVIDED ON PATIENT INJURY OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17879581 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE PATIENT'S HEAD SLIPPED IN THE MAYFIELD MODIFIED SKULL CLAMP (A1059) RESULTING IN ABOUT 2 TO 3 INCHES SKIN LACERATION WHICH WAS STAPLED TO CLOSE. THE CASE WAS DELAYED FOR ABOUT 20 MINUTES; HOWEVER, THE SURGERY WENT WELL.

  Patient problems: Laceration(s)

  MAUDE report 16211392 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2022-00291. A FACILITY REPORTED THAT A PATIENT SUSTAINED A 2MM LACERATION DURING USE OF THE MAYFIELD TRIAD SKULL CLAMP (A1108) WHILE BEING POSITIONED FROM SUPINE TO PRONE. THE TREATMENT REQUIRED SUTURES AND THE MAYFIELD TO BE REMOVED, WHICH DELAYED THE CASE ABOUT 30 MINUTES. THE PATIENT DID WELL AFTER SURGERY.

  Patient problems: Laceration(s)

  MAUDE report 16113916 ↗
• MalfunctionDec 22, 2022Device Slipped; Device Slipped

  A FACILITY REPORTED THAT THE PINS ON MAYFIELD TRIAD SKULL CLAMP (A1108) KEEPS SLIPPING. NO INFORMATION HAS BEEN PROVIDED ON PATIENT INVOLVEMENT, INJURY, OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040396 ↗
• MalfunctionSep 30, 2022Mechanical Problem; Mechanical Problem

  A FACILITY REPORTED THAT THEY EXPERIENCED DIFFICULTY IN PUTTING ON AND OFF THE MAYFIELD TRIAD SKULL CLAMP (A1108) ON A PATIENT. NO PATIENT INJURY OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513521 ↗
• MalfunctionSep 23, 2022Mechanics Altered; Mechanics Altered

  A FACILITY REPORTED THAT THE LOCK ON THE MAYFIELD TRIAD SKULL CLAMP (A1108) WAS TOO LOOSE. THE FACILITY HAS NOT REPORTED IF THERE WAS PATIENT INVOLVEMENT, INJURY, OR SURGICAL DELAY RELATIVE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15474472 ↗
• MalfunctionAug 5, 2022Mechanical Problem; Mechanical Problem

  A FACILITY REPORTED THAT THE LOCK ON THE MAYFIELD TRIAD SKULL CLAMP (A1108) WOULD NOT STAY LOCKED OR HOLD WHEN PATIENT WAS MOVING. THIS OCCURRED DURING A PROCEDURE WITH NO PATIENT HARM, AND DELAY IN SURGERY IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15176135 ↗
• MalfunctionJul 28, 2022Device Slipped; Device Slipped

  A FACILITY REPORTED THAT THE LOCKING MECHANISM ON THE MAYFIELD TRIAD SKULL CLAMP (A1108) MAY HAVE FAILED; THE SURGEON STATED THAT HE FELT IT SLIP WHILE POSITIONING THE PATIENT. THE PATIENT'S HEAD FELL A BIT, BUT THERE WAS NO LACERATIONS AT THE PIN SITES. NO SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15124574 ↗
• InjuryJun 7, 2022Mechanical Problem; Device Slipped; Mechanical Problem; Device Slipped

  A FACILITY REPORTED THAT DURING A POSTERIOR FOSSA TUMOR RESECTION PROCEDURE, THE MAYFIELD TRIAD SKULL CLAMP (A1108) WOULD NOT TIGHTEN DOWN ALL THE WAY AND STAY SECURE. IT SLIPPED WHILE ON PATIENT, CAUSING A CUT/INJURY ON THE RIGHT SIDE OF THE PATIENT'S HEAD, APPROXIMATELY "1 1/2 TO 2" LONG. THERE WAS A DELAY OF 30 TO 45 MINUTES AS THE SURGEON STAPLED THE WOUND CLOSED.

  Patient problems: Laceration(s)

  MAUDE report 14627721 ↗
• MalfunctionMay 24, 2022Device Slipped; Device Slipped

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2022-00104: A FACILITY REPORTED THAT THE MAYFIELD TRIAD SKULL CLAMP (A1108) HAS WORN TEETH AND SLIPS DURING USE. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488277 ↗