Multipurpose Head Frame 07-951-00MMRecalls & reported problems

Mizuho Corporation · Head Holder · 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 04946329272956), received between Jul 28, 2025 and Jul 28, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unstable” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Unstable1

Patient problems

Head Injury1

Recent adverse event reports

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

MalfunctionJul 28, 2025Unstable; Unstable
THIS PRODUCT WAS USED TO IMMOBILIZE THE PATIENT'S HEAD DURING A BRAIN TUMOR REMOVAL SURGERY; HOWEVER, THE JOINTS OF THE HEAD HOLDER COULD NOT BE FULLY SECURED.
Patient problems: Head Injury
MAUDE report 22639793 ↗

Device details

UDI-DI	`04946329272956`
Brand	Multipurpose Head Frame
Model	07-951-00MM
Company	Mizuho Corporation
Product code	HBL · Holder, Head, Neurosurgical (Skull Clamp)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 8, 2021

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.