BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7 X 26MM FULLY THREADED ANGLED LOCKING

    MDR report key: 23406329 · Received October 28, 2025

    Report

    Report Number
    2027754-2025-00055
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    August 28, 2025
    Report Date
    October 28, 2025
    Manufacturer
    OSTEOMED, LLC
    Product Code
    HWC
    UDI-DI
    00845694042635
    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

    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. REPORTS, INCLUDING THIS ONE, FOR THIS COMPLAINT: 2027754-2025-00054, 2027754-2025-00056.

    Additional Manufacturer Narrative · 0

    338-2726 - 2.7 X 26MM FULLY THREADED ANGLED LOCKING SCREW, 4 EACH OF THEM, WERE RECEIVED. THE SCREWS DO NOT SHOW ANY SIGNS OF ABUSE OR BREAKAGE, SO NO FUTURE ACTION ITEMS ARE NECESSARY. NO DEFINITIVE CONCLUSION CAN BE MADE. RELATED REPORTS (INCLUDING THIS ONE): 2027754-2025-00054, 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.

    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
    1703940 2.7 X 26MM FULLY THREADED ANGLED LOCKING SCREW, FIXATION, BONE HWC OSTEOMED, LLC 338-2726 00845694042635

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Other