BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERTAN

    MDR report key: 1023805 · Received April 2, 2008

    Report

    Report Number
    1020279-2008-00106
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 27, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE COMPRESSION SCREW AND NAIL WERE BROKEN. THERE HAS BEEN NO REVISION SURGERY SCHEDULED AS OF TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERTAN INTERNAL FIXATION JDS SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 07DM19033

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other