BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE U-DRILL - EUROPEAN

    MDR report key: 2963109 · Received January 24, 2013

    Report

    Report Number
    1811755-2013-90134
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE MFR, THE DEVICE OPERATED AUTOMATICALLY WITHOUT USER ACTIVATION. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34975 CORE U-DRILL - EUROPEAN ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK