BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11MM

    MDR report key: 13691834 · Received March 7, 2022

    Report

    Report Number
    MW5107917
    Event Type
    Injury
    Date Received
    March 7, 2022
    Date of Event
    February 28, 2022
    Report Date
    March 3, 2022
    Manufacturer
    ACRA-CUT, INC.
    Product Code
    HBF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HISTORY OF PARKINSON'S DISEASE. TO SURGERY (B)(6) 2022 FOR BILATERAL DBS LEAD PLACEMENT (DUAL ARRAYS), ELECTRODE 'PLCMT,' WITH MERS (FIRST ARRAY) - 61867, ELECTRODE 'PLCMT,' WITH MERS (EACH ADDITIONAL ARRAY) - 61868. DURING DRILLING OF THE BURR HOLES WITH A PERFORATOR DRILL BIT, THE DRILL BIT WAS SUPPOSED TO STOP DRILLING BEFORE IT HIT/CUT THE DURA, HOWEVER IT DIDN'T STOP LIKE IT WAS SUPPOSED TO AND IT HIT/CUT THE DURA. THE SURGERY WAS GOING TO HAVE THE DURA AND THE BRAIN ENTERED ANYWAY SO THERE WAS NO HARM IN THIS CASE WITH NO ADDITIONAL CARE. IT ENTERED THE DURA TOO QUICKLY; WASN'T UNDER CONTROL. OCCURRED IN BENIGN AREA OF THE BRAIN. THE SURGERY TEAM RETRIEVED ANOTHER PERFORATOR DRILL BIT BEFORE PROCEEDING WITH DRILLING THE OTHER BURR HOLE. NO HARM IN THIS CASE BUT PER SURGEON IF THIS WOULD HAVE OCCURRED IN A CRITICAL PART OF THE BRAIN IT COULD HAVE BEEN DISASTROUS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527284 DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11MM DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) HBF ACRA-CUT, INC. 10132

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male