BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 2130385 · Received May 9, 2011

    Report

    Report Number
    1811755-2011-01661
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 14, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT WAS EVALUATED BY THE MFR AND THE DEVICE HEATED UP DUE TO HEAVY CORROSION IN THE ATTACHMENT.

    Description of Event or Problem · 1

    THE DEVICE WAS AT THE MFR FOR AN UNRELATED ISSUE AND THE SERVICE TECH FOUND THAT THE DEVICE HEATS UP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL MEDIUM STRAIGHT ATTACHMENT ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK