BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDAS REX LEGEND

    MDR report key: 9890043 · Received March 27, 2020

    Report

    Report Number
    1625507-2020-00039
    Event Type
    Injury
    Date Received
    March 27, 2020
    Report Date
    March 27, 2020
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. THE SURVEY COVERED THE FOLLOWING PRODUCT SYSTEMS THAT WERE USED IN CASES OVER A 12 MONTH PERIOD: MIDAS REX LEGEND SURGICAL DRILL, MIDAS REX MR7 HIGH-SPEED SURGICAL DRILL, STEALTH MIDAS SYSTEM, AND MIDAS REX ELECTRIC BONE MILL. THERE WAS NO SPECIFIC DEVICE MODEL NUMBER OR SERIAL/LOT NUMBER(S) IDENTIFIED OR REPORTED AS PART OF THE SURVEY. THE EVENT DATES WERE NOT PROVIDED IN THE SURVEY. THE SURVEY WAS RANDOMIZED AND PARTICIPANTS WERE GIVEN THE OPTION TO REMAIN ANONYMOUS ON THEIR INPUTS. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE ON THE INITIAL REPORTER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A POST MARKET SURVEY OF 30 PARTICIPANTS IN FOUR (4) COUNTRIES (B)(6) THAT ADVERSE EVENTS MAY HAVE OCCURRED WITH USE OF THE MIDAS REX LEGEND/MR7 HIGH SPEED DRILL AND STEALTH MIDAS SYSTEM. THE SURVEY WAS RANDOMIZED AND PARTICIPANTS WERE GIVEN THE OPTION TO REMAIN ANONYMOUS ON THEIR INPUTS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE RESULTS OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IDENTIFIED ADVERSE EVENTS REPORTED INCLUDES: CSF LEAK, THERMAL TISSUE DAMAGE DUE TO DEVICE OVERHEATING, INFECTION, TRAUMA, ACOUSTIC DAMAGE AND POTENTIAL DAMAGE TO NERVES, TISSUE OR SPINAL CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353846 MIDAS REX LEGEND MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS PSS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other