BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX MR8

    MDR report key: 24892900 · Received April 16, 2026

    Report

    Report Number
    1625507-2026-00655
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    December 4, 2025
    Report Date
    April 16, 2026
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    UDI-DI
    00763000063825
    PMA / PMN Number
    K183515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: EVALUATION DETERMINED THAT THE REPORTED MALFUNCTION OF DIFFICULTY IN LOCKING THE BURR WAS NOT CONFIRMED. THE L IKELY CAUSE COULD NOT BE DETERMINED. IT WAS ALSO NOTED THAT THE DISTAL BEARINGS WERE MISALIGNED. G3: AWARE DATE USED AS DATE OF ANALYSIS PERFORMED DATE AS THE EVENT IS REPORTED BASED ON EVALUATION FINDINGS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE THERE WAS DIFFICULTY IN LOCKING THE BURR. THERE WAS NO PATIENT IMPACT IN THIS EVENT.ADDITIONAL INFORMATION RECEIVED STATING THAT THE BEARINGS WERE MISALIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569695 MIDAS REX MR8 DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MDT POWERED SURGICAL SOLUTIONS MR8-AVA14-R 00763000063825

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown