BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5/4.0 MEDIAL COLUMN FUSION PLATE SHORT

    MDR report key: 23404273 · Received October 28, 2025

    Report

    Report Number
    2027754-2025-00054
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    August 28, 2025
    Report Date
    January 6, 2026
    Manufacturer
    OSTEOMED, LLC
    Product Code
    HRS
    PMA / PMN Number
    K131445
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXAMINATION HAS BEEN PERFORMED; HOWEVER, NO SIGNS OF ABUSE OR BREAKAGE WERE IDENTIFIED. IT IS UNCLEAR WHAT CAUSED THE REPORTED PAIN TO NECESSITATE THE PLATES REMOVAL. COMPLAINT RATE HAS EXCEEDED THE UPPER CONTROL LIMIT FOR THIS MATERIAL GROUP, HOWEVER AS THIS IS THE FIRST REPORTED COMPLAINT FOR THIS PART, NO TREND IS CURRENTLY BEING OBSERVED. NO ROOT CAUSE DETERMINATION CAN BE MADE. RELATED REPORTS (INCLUDING THIS ONE): 2027754-2025-00055, 2027754-2025-00056, 2027754-2026-00001, 2027754-2026-00002, 2027754-2026-00003, 2027754-2026-00004, 2027754-2026-00005, 2027754-2026-00006, 2027754-2026-00007.

    Additional Manufacturer Narrative · 0

    TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "EIGHT YEARS PRIOR TO HIS SURGERY, THE PATIENT REPORTED A TRAUMATIC EVENT DUE TO A FALL FROM A FORMWORK ROOF, LANDING ON THE TIP AND IN ABDUCTION OF THE MIDFOOT, SUBSEQUENTLY PRESENTING OVER THE FOLLOWING YEARS WITH SIGNIFICANT ABDUCTION DEVIATION OF THE LEFT FOOT AT THE EXPENSE OF THE TALONAVICULAR JOINT. THEREFORE, AN ARTHRODESIS OF THE MEDIAL COLUMN OF THE LEFT FOOT WAS PERFORMED WITH A SPECIAL TITANIUM PLATE. THE PATIENT EVOLVED POORLY, WITH PAIN SINCE THE INITIATION OF WEIGHT-BEARING AT 12 WEEKS. AT 11 MONTHS, A REVISION SURGERY WAS PERFORMED, FINDING A TALONAVICULAR PSEUDARTHROSIS AND SEVERE METALLOSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551165 3.5/4.0 MEDIAL COLUMN FUSION PLATE SHORT PLATE, FIXATION, BONE HRS OSTEOMED, LLC 336-3562 1159976

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Other