BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX MR8

    MDR report key: 24680922 · Received March 24, 2026

    Report

    Report Number
    1625507-2026-00248
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 24, 2026
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    UDI-DI
    00763000441227
    PMA / PMN Number
    K183515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3:PRODUCT ANALYSIS: EVALUATION COULD NOT CONFIRM THE REPORTED MALFUNCTION OF OVERHEATING. IT WAS ALSO NOTED THAT THE BEARINGS MISAL IGNED AND LASER MARKINGS ARE FADED. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE EXHIBITED OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742559 MIDAS REX MR8 DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MDT POWERED SURGICAL SOLUTIONS MR8-AVA07 00763000441227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown