BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIX DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END MINI 11/7MM R

    MDR report key: 12975693 · Received December 9, 2021

    Report

    Report Number
    MW5105947
    Event Type
    Injury
    Date Received
    December 9, 2021
    Date of Event
    December 2, 2021
    Report Date
    December 7, 2021
    Manufacturer
    ACRA-CUT INC.
    Product Code
    HBF
    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

    A (B)(6) MALE TAKEN TO THE OPERATING ROOM ON (B)(6) 2021 FOR AN ANTERIOR CRANIAL VAULT RECONSTRUCTION. PT WAS FOUND TO HAVE A SMALL DURAL OPENING RIGHT POSTERIOR FRONTAL UNDER THE CRANIOTOMY SECONDARY TO FAILURE OF PERFORATOR DRILL BIT TO DISENGAGE THE CLUTCH. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863941 MEDTRONIX DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END MINI 11/7MM R DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) HBF ACRA-CUT INC. 10173

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Male Other| R