Midas Rex BM210Recalls & reported problems

Medtronic Powered Surgical Solutions · BONE MILL BM210 LEGEND ELEC DISPOSABLE · Class 1

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 00763000245818), received between Aug 18, 2025 and Aug 18, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Detachment of Device or Device Component1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionAug 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BOTTOM SCREW WAS LOOSE, MAKING ATTACHMENT TO THE MAIN UNIT IMPOSSIBLE. THE PHYSICIAN RE-TIGHTENED THE LOOSENED SCREW, AND THE PROCEDURE WAS COMPLETED. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP NO FURTHER INFORMATION WAS PROVIDED ON PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 22827250 ↗

Device details

UDI-DI	`00763000245818`
Brand	Midas Rex
Model	BM210
Company	Medtronic Powered Surgical Solutions
Product code	LYS · Bone mill
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 7, 2022

Device type (GMDN): Orthopaedic bur, single-use

A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

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