BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRA-CUT

    MDR report key: 21813420 · Received April 10, 2025

    Report

    Report Number
    21813420
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 14, 2025
    Report Date
    March 26, 2025
    Manufacturer
    ACRA CUT, INC
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CRANIAL PERFORATOR DID NOT STOP WHEN IT WENT THROUGH THE CRANIAL BONE RESULTING IN A SMALL DURAL TEAR. PERFORATOR REF 200-271 DGR-O. NO NOTICEABLE DEFECTS IN PERFORATOR, SO IT WAS CHANGED OUT FOR A NEW ONE TO USE FOR SECOND BURR HOLE. 2ND BURR HOLE WENT WITHOUT ISSUE. SMALL AMOUNT OF TISSEEL WAS USED OVER THE DURAL TEAR BEFORE PROCEEDING IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470611 ACRA-CUT DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED) HBF ACRA CUT, INC 14/11MM DGR-O 10674, 10646

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown