BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 5723149 · Received June 13, 2016

    Report

    Report Number
    5723149
    Event Type
    Injury
    Date Received
    June 13, 2016
    Date of Event
    April 26, 2016
    Report Date
    May 29, 2016
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE IN THE OPERATING ROOM FOR THE REMOVAL OF A TEMPORAL MASS, DURING DRILLING OF THE BURR HOLES, THE DRILL PENETRATED THE DURA OF THE BRAIN. THERE WAS NO HARM TO THE PATIENT AND THE REP FOR THE COMPANY WAS CALLED. THE DEVICE WAS GIVEN TO THE REP AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374845 STRYKER INSTRUMENTS ZYPHR DISPOSABLE CRANIAL PERFORATOR HBF STRYKER INSTRUMENTS REF 5100-060-001 SS3170301160770373

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization