BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMED CORTICAL BONE SCREW

    MDR report key: 2630926 · Received June 18, 2012

    Report

    Report Number
    2031009-2012-00011
    Date Received
    June 18, 2012
    Date of Event
    May 24, 2012
    Report Date
    June 1, 2012
    Manufacturer
    TRIMED, INC.
    Product Code
    JDS
    PMA / PMN Number
    K951302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION. DEVICE RETURNED TO MFR. DEVICE WAS FOUND TO HAVE A MFG DEFECT. DEVICE WAS REMOVED AND REPLACED WITH ANOTHER TRIMED SCREW.

    Description of Event or Problem · 1

    DURING SURGERY A 3.2 MM CORTICAL BONE SCREW HEAD BROKE FROM THE SHAFT AS IT HAS BEING INSERTED INTO THE PT. THE SURGEON REMOVED THE SCREW AND REPLACED IT WITH ANOTHER TRIMED 3.2 MM CORTICAL BONE SCREW. THE PT HAD NORMAL BONE QUALITY, AND THE PROVIDED BONE TAP WAS NOT USED PRIOR TO INSERTION OF THE FAILED SCREW INTO THE PT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMED CORTICAL BONE SCREW 3.2 MM CORTICAL BONE SCREW JDS TRIMED, INC. HEX3.2-14 AK028

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention