BEUDAMED
    FDA Adverse Event Summary report: N

    OMNITECH CANNULATED COMPRESSION SCREW

    MDR report key: 2484906 · Received March 8, 2012

    Report

    Report Number
    2031009-2012-00002
    Date Received
    March 8, 2012
    Date of Event
    September 23, 2008
    Report Date
    March 7, 2012
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    PMA / PMN Number
    K050681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION. DEVICE RETURNED TO MFR. DEVICE WAS REMOVED AND REPLACED WITH A SPARE SCREW.

    Description of Event or Problem · 1

    DURING FIXATION OF THE SCREW, THE SURGEON FELT ABNORMAL MOTION. THE SURGEON TOOK AN X-RAY AND NOTICED THE SCREW WAS BROKEN AT THE HEAD. THE SURGEON FELT THAT THE SCREW COULD STILL ACHIEVE NECESSARY FIXATION AND LEFT IT IN THE PT. THE SCREW WAS, HOWEVER, REMOVED AND REPLACED BY A 3.5MM SCREW IN A LATER SURGERY. SUSPECT INVENTORY OF THE PARTS AT TRIMED WAS EVALUATED AND SEGREGATED FOR INSPECTION. PARTS SHOWN TO BE OUT OF TOLERANCE WERE REMOVED FROM INVENTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNITECH CANNULATED COMPRESSION SCREW 3.0MM CANNULATED COMPRESSION SCREW HRS TRIMED, INC. C3024 AA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention