BEUDAMED
    FDA Adverse Event Death Summary report: N

    PD SERIES MAESTRO FIXED DURAGUARD

    MDR report key: 6112183 · Received November 18, 2016

    Report

    Report Number
    0001811755-2016-02749
    Event Type
    Death
    Date Received
    November 18, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIOTOMY FOR A RIGHT LOBAR HEMATOMA, THE PATIENT EXPERIENCED A CARDIAC EVENT AND EXPIRED. PRIOR TO THE SURGERY, THE DURAGUARD WAS FOUND TO LINE UP AND BE IN APPROPRIATE WORKING CONDITION. IT WAS REPORTED BY STAFF THAT AFTER THE PROCEDURE, THE DURAGUARD WAS BENT, POSSIBLY DUE TO EXCESSIVE PRESSURE BEING APPLIED DUE TO A SKULL ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIOTOMY FOR A RIGHT LOBAR HEMATOMA, THE PATIENT EXPERIENCED A CARDIAC EVENT AND EXPIRED. PRIOR TO THE SURGERY, THE DURAGUARD WAS FOUND TO LINE UP AND BE IN APPROPRIATE WORKING CONDITION. IT WAS REPORTED BY STAFF THAT AFTER THE PROCEDURE, THE DURAGUARD WAS BENT, POSSIBLY DUE TO EXCESSIVE PRESSURE BEING APPLIED DUE TO A SKULL ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765958 PD SERIES MAESTRO FIXED DURAGUARD DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) ERL STRYKER INSTRUMENTS-KALAMAZOO 11105

    Patients

    Seq Age Sex Outcome Treatment
    1 Death