BEUDAMED
    FDA Adverse Event Summary report: N

    OMNITECH CANNULATED COMPRESSION SCREW

    MDR report key: 2484907 · Received March 8, 2012

    Report

    Report Number
    2031009-2012-00004
    Date Received
    March 8, 2012
    Date of Event
    November 24, 2009
    Report Date
    March 7, 2012
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    PMA / PMN Number
    K050681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION. DEVICE RETURNED TO MFR BUT WAS LOST OR DISCARDED. DEVICE WAS REMOVED FROM THE PT, REPLACEMENT UNK.

    Description of Event or Problem · 1

    A 24MM LENGTH 2.3MM CANNULATED COMPRESSION SCREW WAS IMPLANTED INTO A PT. THE SCREW BROKE AND WAS REMOVED FROM THE PT. IT IS UNK IF THE SCREW BREAKAGE OCCURRED DURING IMPLANTATION OR DURING PT RECOVERY AFTER SURGERY. F/U ACTIVITIES BY THE SURGEON WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNITECH CANNULATED COMPRESSION SCREW 2.3MM CANNULATED COMPRESSION SCREW HRS TRIMED, INC. C2324 BM

    Patients

    Seq Age Sex Outcome Treatment
    1