BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U2 DRILL

    MDR report key: 2132356 · Received June 13, 2011

    Report

    Report Number
    1811755-2011-02155
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED THE MANUFACTURER AND THE REPORTED FAILURE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL WAS HEATING UP. THE ACCOUNT KNEW NO FURTHER INFORMATION SURROUNDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U2 DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK