BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 2241642 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03200
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 12, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MANUFACTURER AND UPON EVALUATION, THE BROKEN BUR WAS DISCOVERED WITHIN THE DRILL ATTACHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE A BUR BROKE INSIDE THE ATTACHMENT. ANOTHER UNIT WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SD/PD LONG CURVED ERL STRYKER INSTRUMENTS KALAMAZOO 11159

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK