BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW

    MDR report key: 2771995 · Received September 28, 2012

    Report

    Report Number
    2520274-2012-02014
    Event Type
    Injury
    Date Received
    September 28, 2012
    Report Date
    August 30, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MFG RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    ORIGINAL PROCEDURE WAS ORIF OF THE DISTAL FEMUR ON (B)(6) 2012. THE PT RETURNED TO THE SURGEON COMPLAINING OF PAIN. IT IS REPORTED THAT SCREWS WERE BACKING OUT OF THE DISTAL END OF PLATE AND WERE VISIBLE WITH THE NAKED EYE AND ON RADIOGRAPHS. THE PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF THE FOUR (4) LOCKING SCREWS. THE SHAFT OF THE PLATE ALSO CONTAINS SCREWS BUT THOSE SCREWS WERE NOT AFFECTING PT, SO THOSE SCREWS AND THE PLATE REMAIN IMPLANTED. IT IS INTENDED THAT THE SURGEON WILL FOLLOW UP WITH MEDIAL DISTAL FEMUR FIXATION AS WELL AS REAPPLICATION OF THE LOCKING SCREWS AT A LATER DATE. THIS REPORT IS #2 OF 5 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW LOCKING SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention PLATE| SCREWS