MAYFIELD® A1018Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10381780267515), received between Apr 8, 2021 and Mar 13, 2026 — classified as 12 injuries, 24 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Unstable

  THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS 3004608878-2026-00007 AND 3004608878-2026-00030: A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1018) CAME LOOSE DURING SURGERY, RESULTING IN A SINGLE SCRATCH TO THE PATIENT'S HAIRLINE/FOREHEAD, AND A BANDAGE WAS APPLIED TO THE FOREHEAD. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THE SURGERY TIME WAS NOT SIGNIFICANTLY INCREASED.

  Patient problems: Abrasion

  MAUDE report 24597053 ↗
• MalfunctionMar 9, 2026Device Slipped

  THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2026-00025 AND 3004608878-2026-00026: A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1018) WAS PART OF A CERVICAL STABILIZATION CASE WHERE THE PHYSICIAN STATED THAT THE ENTIRE SYSTEM FELT LIKE IT SLIPPED. THE PROCEDURE WAS COMPLETED PER USUAL WITH NO INJURY TO THE PATIENT, WHO IS RECOVERING AS EXPECTED. ADDITIONALLY, THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24549062 ↗
• InjuryFeb 20, 2026Device Slipped

  THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS 3004608878-2026-00018 AND 3004608878-2026-00019: A FACILITY REPORTED THAT THE PATIENT WAS IN THE PRONE POSITION FOR A CRANIOTOMY PROCEDURE AND SLIPPED FROM THE MAYFIELD SWIVEL ADAPTOR (A1018). THIS RESULTED IN AN INCH AND A HALF DEEP LACERATION TO THE PATIENT'S LEFT SCALP WHICH REQUIRED SUTURING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Laceration(s)

  MAUDE report 24405363 ↗
• InjuryFeb 12, 2026Unstable

  THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2026-00010 3004608878-2026-00011. AN AUTHORIZED DISTRIBUTOR REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1018) GAVE WAY AND DID NOT FIX DURING SURGERY. THE INCIDENT CAUSED AN INCREASE IN SURGICAL TIME OF MORE THAN 30 MINUTES, DUE TO THE NEED TO MANAGE THE SITUATION. THERE WAS NO DEATH, BUT RATHER LACERATIONS TO THE SCALP, CONSTITUTING AN INJURY ASSOCIATED WITH THE EVENT. THE EVENT OCCURRED IN (B)(6) HOSPITAL.

  Patient problems: Laceration(s)

  MAUDE report 24329069 ↗
• MalfunctionNov 26, 2025Device Slipped; Device Slipped

  THIS IS 4 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2025-00223 3004608878-2025-00224. 3004608878-2025-00225. THE MAYFIELD MODIFIED SWIVEL ADAPTOR (A1018) WAS BEING USED FOR A POSTERIOR CERVICAL PROCEDURE, AND THE FACILITY'S SURGEON REPORTED THAT HE THOUGHT HE FELT A SLIP WHEN HE DRILLED. THE PATIENT WAS UNHARMED, AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662848 ↗
• InjuryNov 6, 2025Device Slipped; Device Slipped

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2025-00198: A FACILITY REPORTED THAT THE PART OF THE MAYFIELD HEADREST THAT HOLDS THE HEAD IN PLACE CAME LOOSE/MOVED AWAY ON ITS OWN WHEN POSITIONING THE HEAD OF THE PATIENT. THE PATIENT WAS BLEEDING DURING THE SURGERY, AND A BANDAGE WAS APPLIED ON THE PATIENT'S WOUNDS. THE SURGERY WAS FINALIZED BY SECURING THE HEAD WITH THE HEADREST AND A FOAM CUSHION TO HOLD THE HEAD IN PLACE IN CASE IT SLIPPED AGAIN. THE SURGERY TIME WAS INCREASED BY 1 HOUR.

  Patient problems: Laceration(s)

  MAUDE report 23490586 ↗
• MalfunctionOct 31, 2025Unstable; Unstable

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2025-00206: A RESIDENT PHYSICIAN REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1018) WAS USED FOR A CASE ALONG WITH THE INTEGRA MAYFIELD BED ATTACHMENT, BASE UNIT, SKULL CLAMP, AND PINS. THE RESIDENT PLACED THE SKULL CLAMP AND IT WAS CHECKED BY THE ATTENDING SURGEON. DURING THE CASE, THEY FELT SOMETHING SHIFT AND CHECKED THE PATIENT¿S HEAD POSITION WITHIN THE SKULL CLAMP AND IT WAS THE SAME; NOTHING MOVED. AT THE END OF THE CASE WHEN THE PATIENT WAS FLIPPED TO THE BED AND THE SKULL CLAMP WAS REMOVED, THE RESIDENT NOTICED AN INDENTATION ON THE PATIENT¿S NOSE. THE ROUND CONNECTION POINT WHERE THE SKULL CLAMP MEETS THE SWIVEL ADAPTOR WAS PRESSING AGAINST THE PATIENT¿S NOSE. THE RESIDENT CONFIRMED THE EXTRA POP FEELING WHEN LOCKING THE SKULL CLAMP AND THERE WAS NO PLAY IN THE MAYFIELD SET UP. HE ALSO CHECKED THE PATIENTS SCALP FOR ANY LACERATIONS AND THERE WERE NONE. THE BASE UNIT USED IN THIS PROCEDURE IS UNKNOWN, AS IT WAS NOT FLAGGED WITH THE OTHER EQUIPMENT AFTER THE PROCEDURE. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437751 ↗
• MalfunctionOct 17, 2025Unstable; Unstable

  A FACILITY REPORTED THAT USERS REPORT THAT BY FIXING THE HEADBOARD OF THE MAYFIELD SWIVEL ADAPTOR (A1018) ON LOCK, THE PATIENT IS NOT STABLE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23325310 ↗
• InjuryJul 21, 2025Unstable; Unstable

  THIS IS 3 OF 4 REPORTS FOR THE MAYFIELD SYSTEM LINKED TO MFG REPORT NUMBERS: 3004608878-2025-00148. 3004608878-2025-00149. 3004608878-2025-00150. A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1018) NEEDS TO BE CHECKED AS IT GOT LOOSE/BECAME UNLOCKED DURING SURGERY, RESULTING IN WHIPLASH FOR THE PATIENT. IT IS UNCLEAR IF THE EVENT LED TO INCREASED SURGERY TIME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Neck Stiffness

  MAUDE report 22555440 ↗
• MalfunctionMay 21, 2025Mechanics Altered; Mechanics Altered

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2025-00107: A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1018) WAS USED IN A CASE, AND THE JOINT COULD NOT HOLD. AS A RESULT, THE DEVICE WAS CHANGED. THERE WAS NO PATIENT INJURY; HOWEVER, THERE WAS SIGNIFICANT INCREASED SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060423 ↗
• MalfunctionMay 8, 2025Unstable; Unstable

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2025-00092. A FACILITY REPORTED THE FOLLOWING RE THE MAYFIELD MODIFIED SKULL CLAMP (A1059): "STRUCTURE GAVE WAY DURING THE SURGERY." ADDITIONAL INFORMATION HAS BEEN REQUESTED. END USER: (B)(6) PORTUGAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21988486 ↗
• MalfunctionMay 8, 2025Unstable; Unstable

  A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1018) GAVE WAY DURING SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21985212 ↗
• MalfunctionApr 24, 2025Unstable; Unstable

  THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS 3004608878-2025-00079 AND 3004608878-2025-00080: A FACILITY REPORTED THAT ONCE FIXED, THE MAYFIELD SWIVEL ADAPTOR (A1018) 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 21902065 ↗
• MalfunctionMar 20, 2025Degraded; Degraded

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657323 ↗
• MalfunctionFeb 13, 2025Device Slipped; Device Slipped

  THIS REPORT IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2025-00022 3004608878-2025-00025 A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1059) WAS SLIPPING AND NOT MAINTAINING THE FULL POSITION DURING SURGERY. ANOTHER HEADREST WAS USED TO COMPLETE THE SURGERY, AND THERE WAS NO DELAY OR PATIENT INJURY REPORTED. FACILITY HAS INDICATED THAT THE COMPLETE MAYFIELD SYSTEM IS BEING RETURNED TO KEEP ALL PARTS TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381340 ↗
• InjuryNov 27, 2024Device Slipped; Device Slipped

  N/A

  Patient problems: Abrasion

  MAUDE report 20803095 ↗
• InjuryNov 20, 2024Unstable; Unstable

  THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2024-00131 3004608878-2024-00132. A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1018) WAS NOT HOLDING, AND THE PATIENT'S HEAD SLIPPED AND GRAZED DURING THE SURGERY. NO INFORMATION ON MEDICAL INTERVENTION HAS BEEN PROVIDED.

  Patient problems: Abrasion

  MAUDE report 20734729 ↗
• InjuryApr 5, 2024Unstable; Unstable

  THIS REPORT IS LINKED TO MFG REPORT NUMBERS 3004608878-2024-00018 AND 3004608878-2024-00019: A FACILITY REPORTED THAT DURING USE OF THE MAYFIELD SWIVEL ADAPTOR (A1018) THE STAFF ASSISTED IN TURNING THE PATIENT TO THE PRONE POSITION ONTO THE OPERATIVE TABLE, AND UPON ADJUSTING THE HEAD CLAMP TO THE DESIRED POSITION, STAFF NOTICED THE CLAMPS SHIFTING AND NOT ADEQUATELY LOCKING. THE HEAD PINS AND CLAMP WERE REPOSITIONED AND APPLIED; HOWEVER, THE POSITIONING WAS STILL NOT OPTIMAL. BLEEDING FROM PIN SITES OCCURRED AND ORIGINAL PIN SITES WERE STAPLED CLOSED. A REPLACEMENT HEADREST WAS USED AND THE MAYFIELD PINS, BASE AND CLAMP WERE QUARANTINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19051004 ↗
• MalfunctionJan 12, 2024Device Slipped; Device Slipped

  A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR ((B)(6)) SLIPPED ON A PATIENT DURING AN UNSPECIFIED CASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18508709 ↗
• InjuryJan 2, 2024Device Slipped; Device Slipped

  THIS IS 2 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2023-00242, 3004608878-2023-00244, 3004608878-2023-00243. A FACILITY REPORTED THAT DURING A POSTERIOR CERVICAL LAMINECTOMY WITH LAMINOPLASTY PROCEDURE, THE MAYFIELD SWIVEL ADAPTOR (A1018) SLIPPED, RESULTING IN A 1-2CM LACERATION ON THE RIGHT SIDE OF THE PATIENT'S HEAD. NO INTERVENTION WAS PERFORMED. HOWEVER, THE PATIENT HAD TO BE TRANSFERRED BACK TO LITTER UNTIL ANOTHER MAYFIELD COULD BE OBTAINED RESULTING IN SURGICAL DELAY OF APPROXIMATELY 2 HOURS WHILE THE PATIENT WAS INTUBATED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITHOUT FURTHER ISSUE. PATIENT IS CAUCASIAN, 'NOT HISPANIC OR LATINO.'

  Patient problems: Laceration(s)

  MAUDE report 18430870 ↗
• MalfunctionJun 9, 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 3004608878-2023-00111: A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1018) 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 17100886 ↗
• MalfunctionApr 21, 2023Device Slipped; Device Slipped

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788343 ↗
• InjuryFeb 4, 2023Device Slipped; Device Slipped

  THIS REPORT IS 2 OF 3 AND LINKED TO MFG REPORT NUMBERS 3004608878-2023-00014 AND 3004608878-2023-00016: A FACILITY REPORTED THAT WHILE THE MAYFIELD SYSTEM (A1018 MAYFIELD SWIVEL ADAPTOR) WAS IN CONTACT WITH A PATIENT FOR AN UNSPECIFIED PROCEDURE, A PROBLEM OCCURRED AND THE PATIENT WAS INJURED. ADDITIONAL INFORMATION RECEIVED STATES THAT "WHEN PALPATING THE ANATOMICAL RELATIONSHIPS, THE PATIENT'S HEAD IN THE MAYFIELD HAD MOVED 15 DEGREES FROM THE (HORIZONTAL) POSITION." THE PROBLEM LED TO INCREASED SURGERY TIME.

  Patient problems: Insufficient Information

  MAUDE report 16301169 ↗
• InjuryDec 22, 2022Mechanical Problem; Mechanical Problem

  THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS 3004608878-2022-00282 AND 3004608878-2022-00283: A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1108) FAILED AND RESULTED IN AN UNSPECIFIED PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16040352 ↗
• MalfunctionAug 19, 2022Device Slipped; Device Slipped

  THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00168, 3004608878-2022-00169. A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1018) SLIPPED ON A PATIENT. THE DEVICE WAS IN CONTACT WITH THE PATIENT; HOWEVER, NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15260060 ↗