BEUDAMED
    FDA Adverse Event Summary report: N

    OMNITECH CANNULATED COMPRESSION SCREW

    MDR report key: 2484908 · Received March 8, 2012

    Report

    Report Number
    2031009-2012-00006
    Date Received
    March 8, 2012
    Date of Event
    October 5, 2011
    Report Date
    March 7, 2012
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    PMA / PMN Number
    K050681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION. DEVICE NOT RETURNED TO MFR. DEVICE WAS LEFT IN PT.

    Description of Event or Problem · 1

    THREE MONTHS AFTER SURGERY, A 25MM LENGTH 2.3MM CANNULATED COMPRESSION SCREW BROKE IN A PT. THE PT WAS IN A POST-OPERATIVE CAST AND DID NOT FALL OR UNDERGO ANY EXTREME ACTIVITY TO CAUSE THE BREAKAGE. NOTHING WAS DONE TO REMOVE THE BROKEN SCREW FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNITECH CANNULATED COMPRESSION SCREW 2.3MM CANNULATED COMPRESSION SCREW HRS TRIMED, INC. C2325 BO

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention