BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CABLE/WIRE

    MDR report key: 2575875 · Received May 10, 2012

    Report

    Report Number
    2520274-2012-00779
    Event Type
    Injury
    Date Received
    May 10, 2012
    Report Date
    April 13, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    DZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR PART NUMBER OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PT TREATED WITH PLATE AND SCREW FIXATION FOR DISTAL FEMUR FRACTURE, RETURNED TO SURGEON ON UNK DATE COMPLAINING OF PAIN. X-RAYS SHOWED A NON-UNION OF THE DISTAL FEMUR ALONG WITH 4 BROKEN CORTICAL SCREWS, A CONICAL SCREW THAT WAS BACKING OUT AND AN UNK BROKEN WIRE/CABLE. PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR HARDWARE REMOVAL OF THE PLATE, 7 SCREWS AND WIRE/CABLE. PT WAS REVISED TO A LONGER PLATE BONE GRAFT. THIS IS THE 7TH OF 7 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CABLE/WIRE DZK SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention PLATE| SCREWS