BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDAS REX®LEGEND FOOTED ATTACHMENT

    MDR report key: 8461699 · Received March 28, 2019

    Report

    Report Number
    1625507-2019-00019
    Event Type
    Injury
    Date Received
    March 28, 2019
    Report Date
    June 28, 2019
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN. NO EVALUATION WAS PERFORMED, AS THE DEVICE WAS NOT RETURNED. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THE DEVICE USER MANUAL WARNINGS SECTION INCLUDES INSTRUCTIONS TO CHECK THE DEVICE FOR DAMAGE BEFORE USE. IF DAMAGE IS FOUND, THE DEVICE SHOULD NOT BE USED. WE WILL CONTINUE TO TRACK AND TREND THIS COMPLAINT TYPE. (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE (CHILDS NERV SYST (2010) 26: 953¿955, DOI 10.1007/S00381-010-1139-5) THAT ONE PATIENT HAD A DURAL TEAR ALONG THE INFERIOR ASPECT OF THE CRANIOTOMY NOT EXTENDING INTO THE FORAMEN MAGNUM. THERE WAS NO INSTANCE OF VENOUS SINUS INJURY OR UNDUE BLEEDING FROM THE BURR HOLE. NONE OF THE PATIENTS HAD AN INFECTION REQUIRING REMOVAL OF THE BONE FLAP. NO ADDITIONAL INFORMATION WAS PROVIDED DURING FOLLOW UP.

    Description of Event or Problem · 1

    ON FOLLOW UP, IT WAS CONFIRMED THAT THERE WAS NO ADDITIONAL INTERVENTION PERFORMED AND THERE WERE NO SIDE EFFECTS RELATED TO THE DURAL TEAR. NO FURTHER INFORMATION WAS PROVIDED REGARDING DEVICE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252714 MIDAS REX®LEGEND FOOTED ATTACHMENT MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS AF02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other