MAYFIELD® A1084Recalls & reported problems

Integra Lifesciences Corporation · MAYFIELD® Disposable Child Skull Pin (Stainless Steel) · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780025795), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

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

Device problems

Manufacturing, Packaging or Shipping Problem1
Unclear Information1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 6, 2022Manufacturing, Packaging or Shipping Problem; Unclear Information; Manufacturing, Packaging or Shipping Problem; Unclear Information
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2022-00253: A FACILITY REPORTED THAT ONE OF THE SURGEONS WAS ABOUT TO USE PEDIATRIC PINS ON AN ADULT PATIENT, BUT FORTUNATELY REALIZED PRIOR TO THE CASE AND THE PINS WERE CHANGED. NURSE MANAGER BELIEVES THAT THE MAIN REASON WAS THAT THE PACKAGING FOR A1083 MAYFIELD ADULT PINS AND A1084 MAYFIELD PEDIATRIC PINS LOOKS SIMILAR IN SIZE AND THE PIN PROTECTORS ARE BOTH BLUE. THERE WAS NO PATIENT CONTACT AND NO DELAY IN SURGERY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15924241 ↗

Device details

UDI-DI	`10381780025795`
Brand	MAYFIELD®
Model	A1084
Company	Integra Lifesciences Corporation
Product code	HBL · HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
Class	Class 2
FDA submission	K941558
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	May 11, 2023

Device type (GMDN): Skull clamp

A U-shaped surgical device intended to hold the head and neck in a particular fixed position during surgical procedures. It is connected to the skull with screws or pins (not included), typically on each side of the forehead, whilst the other end is fixed to an operating table or chair. Commonly known as a Mayfield skull clamp, it is made of metal materials (non-radiolucent) and may have adjustable joints (either incorporated or separate) for positioning/stabilization; it is not intended for applying traction forces to the cervical spine. This is a reusable device.

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All HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.