MAYFIELD® A1114ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10381780253556), received between Nov 19, 2021 and Jan 29, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Device Slipped

  N/A.

  Patient problems: Laceration(s)

  MAUDE report 24209621 ↗
• MalfunctionMar 1, 2024Unintended Movement; Unintended Movement

  A FACILITY HAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE PATIENT'S HEAD MOVED IN THE MAYFIELD INFINITY SKULL CLAMP (A1114). THERE WAS NO PATIENT INJURY AND NO KNOWN DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18819516 ↗
• InjuryOct 12, 2023Difficult to Remove; Difficult to Remove

  N/A.

  Patient problems: Laceration(s)

  MAUDE report 17924103 ↗
• MalfunctionAug 19, 2022Device Slipped; Device Slipped

  THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00167 3004608878-2022-00169A FACILITY REPORTED THAT THE MAYFIELD INFINITY SKULL CLAMP (A1114) 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 15260069 ↗
• InjuryMay 13, 2022Device Slipped; Device Slipped

  MEDWATCH WITH MDR REPORT #(B)(4) WAS RECEIVED: "PATIENT IN OPERATING ROOM FOR CRANIOTOMY FOR TUMOR EXCISION. PATIENT POSITION WITH MAYFIELD SKULL CLAMP DURING CASE BY MD. DURING SKIN CLOSURE, PATIENTS HEAD SLIPPED OUT OF PINS CAUSING A 0.5 INCH AND 0.25 INCH LACERATION ON FOREHEAD. LACERATION SUTURED CLOSED." ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED: PER THE PHYSICIAN'S NOTES: ¿AFTER THOROUGH PREOPERATIVE EVALUATION, THIS PATIENT WAS BROUGHT TO THE OPERATING ROOM PLACED ON THE OPERATING TABLE IN A SUPINE POSITION. HER LEFT SHOULDER WAS GENTLY BUMPED USING A SHOULDER ROLL, AND THE HEAD TURNED TO THE RIGHT THUS EXPOSING THE TEMPOROPARIETAL AREA. HER HEAD WAS AFFIXED IN A MAYFIELD HEAD HOLDER.¿ THE PATIENT WAS NOT REPOSITIONED. APPROXIMATELY 2.5 HOURS WAS THE LENGTH OF TIME THE PRODUCT WAS IN USE BEFORE THE EVENT OCCURRED. 60-65 POUNDS PRESSURE WAS APPLIED TO THE PATIENT. THERE WAS NO DELAY IN SURGERY REPORTED. PATIENT WAS REMOVED FROM THE MAYFIELD AND NORMAL PADDED OR HEAD PIECE WAS REPLACED AFTER INCISION WAS CLOSED. PHYSICIAN ASSISTANT CLOSED 1 SITE WITH SUTURE AND 1 WITH STAPLES. THE OTHER SITE DID NOT REQUIRE CLOSURE. LACERATIONS WERE EITHER SUTURED OR STAPLED FOR CLOSURE

  Patient problems: Laceration(s)

  MAUDE report 14396035 ↗
• MalfunctionNov 19, 2021Mechanical Jam; Mechanical Jam

  A FACILITY REPORTED THAT THE TRANSITIONAL ON THE MAYFIELD ULTRA BASE UNIT (A2101) IS STUCK IN PLACE DUE TO HOLE BEING DEFORMED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846119 ↗