BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMED CORTICAL BONE SCREW

    MDR report key: 2484880 · Received March 8, 2012

    Report

    Report Number
    2031009-2012-00005
    Date Received
    March 8, 2012
    Date of Event
    May 2, 2011
    Report Date
    March 7, 2012
    Manufacturer
    TRIMED, INC.
    Product Code
    JDS
    PMA / PMN Number
    K951302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION. DEVICE NOT RETURNED TO MFR. DEVICE WAS REMOVED AND REPLACED WITH A COMPETITOR'S SCREW.

    Description of Event or Problem · 1

    DURING SURGERY A 3.2MM CORTICAL BONE SCREW HEAD BROKE FROM THE SHAFT AS IT WAS BEING INSERTED INTO THE PT. THE SURGEON REMOVED THE SCREW WITH PLIERS AND REPLACED IT WITH A COMPETITOR'S 3.5MM SCREW. THE PT HAD HARD BONE QUALITY, WHICH CAUSE THE COMPETITOR'S HEX SCREW SOCKET TO START STRIPPING DURING THE SECOND INSERTION ATTEMPT. ALL OTHER SCREWS INSERTED WERE FROM TRIMED. THE PROVIDED BONE TAP WAS USED TO PREVENT BREAKAGE IN OTHER SCREW HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMED CORTICAL BONE SCREW 3.2MM CORTICAL BONE SCREW JDS TRIMED, INC. HEX3.2-14 102774-01

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention