BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKING SCREW 3.5, 16MM, T15, TI

    MDR report key: 10557182 · Received September 18, 2020

    Report

    Report Number
    2031009-2020-00004
    Event Type
    Injury
    Date Received
    September 18, 2020
    Date of Event
    August 24, 2020
    Report Date
    July 19, 2021
    Manufacturer
    TRIMED, INC.
    Product Code
    HWC
    UDI-DI
    00842188120688
    PMA / PMN Number
    K192696
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RETURN AND INSPECTION OF THE DEVICE IT WAS DETERMINED THAT THE DEVICE HAD DAMAGED THREADS LIKELY CAUSING THE SCREW TO NOT PROPERLY LOCK INTO THE PLATE CAUSING THE SCREW TO BACK OUT OF THE PLATE.

    Description of Event or Problem · 1

    A TRIMED SALES REP LOCATED IN THE UNITED STATES REPORTED ON (B)(6) 2020 THAT A SCREW (TRXV3.5-16 T) HAD STARTED BACKING OUT FROM THE PLATE AND BONE OF THE PATIENT. THE SCREW AND PLATE WAS ORIGINALLY IMPLANTED ON (B)(6) 2020, THE HEALING TIME FOR THIS PLATE AND SCREW IS ABOUT 6 WEEKS TO COMPLETE FIXATION. IN (B)(6) THE PATIENT STARTED EXPERIENCING IRRITATION AT THE IMPLANT SITE AND WHERE THAT SCREW WAS PLACED. AN X-RAY WAS TAKEN OF THE IMPLANT AND IT WAS DETERMINED THAT ONE OF THE SCREWS STARTED TO BACK OUT. THE SCREW WAS THEN REMOVED ON (B)(6) 2020, THE REST OF THE PLATE AND SCREWS WERE LEFT IN THE PATIENT AS THEY WERE NOT CAUSING ANY ADDITIONAL HARM, AND THE REST OF THE CONSTRUCT WAS HOLDING UP. THE SURGEON NOTED THAT THE JOINT WAS FUSED AND FIXATION HAD BEEN ACHIEVED, AND STATED THE REMOVAL DID NOT CAUSE ANY ADDITIONAL HARM TO THE PATIENT. THE SCREW WAS RETURNED TO TRIMED TO AID IN THE INVESTIGATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017495 VA LOCKING SCREW 3.5, 16MM, T15, TI VA LOCKING SCREW 3.5, 16MM, T15, TI HWC TRIMED, INC. TRXV3.5-16 T 00842188120688

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention