BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5TH MET SCREW 4.5, 55MM

    MDR report key: 10550707 · Received September 17, 2020

    Report

    Report Number
    2031009-2020-00003
    Event Type
    Injury
    Date Received
    September 17, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 17, 2020
    Manufacturer
    TRIMED, INC
    Product Code
    HRS
    UDI-DI
    00842188107184
    PMA / PMN Number
    K112794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A TRIMED SALES REP LOCATED IN THE UNITED STATES REPORTED ON (B)(6) 2020 THAT A ACREW (JHEX4555) HAD BROKEN IN THE PATIENT. THE PATIENT STATED THAT WHILE PLAYING BASKETBALL HE FELL AND BROKE HIS TOE ALONG WITH THE SCREW THAT WAS IMPLANTED 2 YEARS PRIOR, X-RAY IMAGES WERE TAKEN TO CONFIRM THAT THE TOE AND SCREW HAD BOTH BROKEN. THE SCREW WAS ORIGINALLY IMPLANTED ON (B)(6) 2018, AND WAS REMOVED ON (B)(6) 2020. THESE SCREWS ARE DESIGNED TO STAY IN THE PATIENT FOREVER. AFTER, THE REMOVAL OF THE SCREW A NEW PLATE AND SCREWS WERE PLACED ON THE BONE TO ACHIEVE FIXATION OF THE NEW BREAK. THE SURGEON REPORTED THAT THIS DID NOT CAUSE THE PATIENT ANY FURTHER HARM. AS OF (B)(6) 2020, THE PATIENT IS HEALING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015709 5TH MET SCREW 4.5, 55MM 5TH MET SCREW 4.5, 55MM HRS TRIMED, INC JHEX4555 00842188107184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention