BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO STRAIGHT AM ATTACHMENT

    MDR report key: 2230992 · Received July 19, 2011

    Report

    Report Number
    1811755-2011-02609
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIOTOMY, THE DRILL ATTACHMENT LEAKED FLUID. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, WITHOUT CAUSING A DELAY. NO MEDICAL INTERVENTION OR ADDITIONAL TREATMENT WAS REQUIRED FOR THE PT. NO PT OR USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE USER FACILITY WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO STRAIGHT AM ATTACHMENT HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK